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VAERS ID:359255 (history)  Vaccinated:2009-09-24
Age:44.0  Onset:2009-09-24, Days after vaccination: 0
Gender:Female  Submitted:2009-10-03, Days after onset: 9
Location:North Carolina  Entered:2009-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nil
Preexisting Conditions: Nil
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 5IJLA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Blood glucose increased, Blood pressure decreased, Burning sensation, Dizziness, Dyspnoea, Electrocardiogram, Erythema, Faecal incontinence, Feeling cold, Livedo reticularis, Micturition urgency, Ocular hyperaemia, Oxygen saturation decreased, Pallor, Pruritus, Urinary incontinence
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad)
Write-up: First felt with whole body with burning sensation,severe urge to urinate.Went to bathroom ,lost control with bowel&bladder.While urinating hands $ whole scalp was itching.Then noticed with mottled skin on bilateral thighs & face & eyes were very red.Felt very weak.Somehow came out of bathroom,Could not even walk,called for help.Felt like passout,Short of breath.As per viewers ,I became very pale white grayish in color.I felt like I am dying .BP 90/50.Blood glucose 102,Oxygenation was 60-70%.Given O2 & taken me to ER.During this time I was cant even talk/stand.ER did all labs,EKG, By 6 PM On & Off becoming pale & body is cold.by 7.30 pm got Benadryl 25mg IV.Then slept for 15 mts,woke up ,felt very good.Then given me Inj Solumedrol 125 mg IV.By 830 got discharged.walked to parking lot.Discharged with Prednisone 60 mg x3 days & Benadryl 25 mg TID x 3 days.I was very weak for a week.Now I feel Okay.

VAERS ID:359256 (history)  Vaccinated:2009-10-01
Age:70.0  Onset:2009-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-10-03, Days after onset: 2
Location:Minnesota  Entered:2009-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pneumonia shot given as well
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS01120 RA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.47390 LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:
Write-up: Arm began to ache in shoulder and I was unable to lift my arm above my waist. I took two Advil about 10:00 PM, awakened the second time about 5:00 AM (Oct 2) and the entire shoulder bone ached and was still unable to move my arm above the waist. I talked with our medical nurse and she advised me to go to the emergency room. He advised taking Advil (up to 800 mg) and the pain should subside in a day or two. It has improved greatly in the last 24 hours.

VAERS ID:359257 (history)  Vaccinated:2009-09-28
Age:57.0  Onset:2009-09-28, Days after vaccination: 0
Gender:Female  Submitted:2009-10-03, Days after onset: 5
Location:Florida  Entered:2009-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paroxetine 20mg 2xd;Enalapril 20mg 2xd;Symbicort 160/4.5 2xd; Proventil HFA;
Current Illness: no
Preexisting Conditions: COPD, HTN , Chronic Depression
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Decreased appetite, Delirium, Dizziness, Fatigue, Feeling abnormal, Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Nausea, Nightmare, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Felt dizzy and nauseous, very tired went to sleep for several hours. Didnt feel like eating and had a headache. Injection site very warm and reddish. Went to bed and woke up at @1:30 AM with excruciating pain in arm..took asprin..very woozy and delirious..had vivid nightmares..arm very very painful...put cold pack around arm and fell asleep. Did not wake up until about 9:30 AM 09/29/2009..knuckles hurt, knees hurt,hips hurt injection site lobster red and swollen felt feverish, no temp. redness appeared to wrap around arm...couldn''t stay awake went back to bed and slept 3-4 hours..called health dept. they were to call back. Felt worse as day progressed. 09/30/2009..fainted when making coffee,felt horrible, called health department. P.A. called back in afternoon and said drink fluids, take tylenol and alternate with ibuprofen..ice packs only (Ihad asked about heat)..keep eating and monitor temp.None to date. Checked back w/health dept. next day left message and no return call. This is 10/03/2009 and I am really starting to feel human again. Redness completely gone from site, but I still am experiencing some joint pain, hardness at site and solar plexus pain. I think I am going to live...it really felt like the Flu I experienced 3 years ago, but the P.A. said it probably wasn''t the Flu vaccine, it was the PPSV. Thank goodness you only get it once every 5 years.

VAERS ID:359258 (history)  Vaccinated:2009-09-24
Age:31.0  Onset:2009-09-25, Days after vaccination: 1
Gender:Male  Submitted:2009-10-03, Days after onset: 8
Location:Utah  Entered:2009-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None to the above and I am currently not on any medications.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Tested for N1H1 9/28/2009: results reported negative on 09/29/2009.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Unknown     Purchased by: Public
Symptoms: Dysgraphia, Fatigue, Influenza serology negative, Muscular weakness, Musculoskeletal stiffness, Myalgia, Oropharyngeal pain, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Sore throat. Stiffness of muscles: 8 out of 10 level of pain that lasted four days. Pain only occurred when moved: if kept still no pain. Pain was like every muscle had been ripped or pulled. Which muscles had extreme pain: legs, stomach, back, arms. Extreme pain finally subsided 10/01/2009, replaced with weakness in arms, struggle to write and lift objects, and constant fatigue. Went to the doctors on 09/28/2009 and reported extreme pain: tested for N1H1: results reported negative on 09/29/2009. I believe that this has been an allergic reaction to the flu shot.

VAERS ID:359259 (history)  Vaccinated:2009-09-21
Age:76.0  Onset:2009-09-26, Days after vaccination: 5
Gender:Male  Submitted:2009-10-03, Days after onset: 7
Location:New York  Entered:2009-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0IDLA
Administered by: Private     Purchased by: Private
Symptoms: Pain in extremity
SMQs:
Write-up: Pain on side of vaccine administration.

VAERS ID:359260 (history)  Vaccinated:2009-09-25
Age:1.5  Onset:2009-10-01, Days after vaccination: 6
Gender:Male  Submitted:2009-10-03, Days after onset: 2
Location:Georga  Entered:2009-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS 2 RL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0 RL
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Fever followed by red pin prick rash on torso and upper back

VAERS ID:359261 (history)  Vaccinated:2009-09-29
Age:29.0  Onset:2009-09-30, Days after vaccination: 1
Gender:Male  Submitted:2009-10-03, Days after onset: 3
Location:New York  Entered:2009-10-03
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
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA283AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:
Write-up: Enlarged nodes in neck on the right side just above the collar bone. Sore like a bruise, especially to touch.

VAERS ID:359262 (history)  Vaccinated:2009-09-19
Age:53.0  Onset:2009-09-20, Days after vaccination: 1
Gender:Female  Submitted:2009-10-03, Days after onset: 13
Location:New York  Entered:2009-10-03
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: DOCTOR OFIICE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA474CA IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Disorientation, Dizziness, Dysstasia, Gait disturbance, Headache, Hypophagia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: HIGH FEVER OF 103 LAST UNTIL 09/21/09 4 AM, THN START TO GO DOWN TO 101 09/22/09 WENT DOWN O 99, WEAKNESS, DIZZENESS, NOT ABLE TO EAT OR DRINK, HEADACH SEVER PAIN IN MY KNEE & MY BACK, NOT ABLE TO STAND OR WALK I FELT VERY WEAK DISORINTED NOT GET UP FROM BED FOR 36HRS, IHAVE TO USE ICE PK ON MY HEAD, TAKING TYLENOL 650 MG Q4HR AROUND THE CLOCK & IBUPROFEN AT LEAST 4 TIMES A DAY ON SUNDAY, .PROBLEM TO BREATH, CHILLIS.CONTACT MY PHYSICAIN ON sunday 09/20/2009 10 pm he ask me to go to ER IN OVERLOOK HOSPITAL IN NJ OR IF I CAN WAIT TO BE SEEN IN THE NMORNING IN THE OFFICE, HE SAID IT IS UNLIKLY THAT I HAD THE FLU BECAUSE THE VACCINE IS INACTIVE, I SW MY DOCTOR ON MON DAY 09/21/2009 AROUND NOON TIME STILL HAD A FEVR, HE SAID HIGH FEVER IS NOT ACOMMON SIDE EFFECT OF VACCINE, HE ASK ME TO REST & NOT TO GO TO WORK UNTIL I FEEL BETTER CONTINUE TYLENOL & IF TEMP DOES NOT GOE WITHIN 24HR I HAVE TO GO BACK TO THE OFFICE,BY TUES 09/22/09 10 AM I FELT BETTER, I DID NOT GO BACK TO THE OFFICE , IWENTBACK TO WORK, IDID NOT REPORT THIS YET AT BELLEVUE HOSPITAL BUT I WILL.

VAERS ID:359263 (history)  Vaccinated:2009-09-16
Age:15.0  Onset:2009-09-19, Days after vaccination: 3
Gender:Female  Submitted:2009-10-03, Days after onset: 14
Location:Georga  Entered:2009-10-03
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 PMH: Anorexia Nervosa, Amenorrhea Allergies: NKDA
Diagnostic Lab Data: Blood work, sugar level check, EKG and ECO all negative. Labs: CBC, CRP, CMP, complement studies, ANA profile, ESR, TSH, Ferritin WNL Dx tests: Echo, Holter monitoring, EKG WNl
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3209AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0672Y1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Antinuclear antibody negative, Blood test normal, Blood thyroid stimulating hormone, C-reactive protein normal, Complement factor normal, DNA antibody, Echocardiogram normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Full blood count, Heart rate increased, Incoherent, Laboratory test normal, Loss of consciousness, Red blood cell sedimentation rate normal, Serum ferritin normal, Skin discolouration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Syncope - Running a 5K, child is a half marathoner and 5K state champion. Pulse went to 172. Ash gray in face and memory loss of event. This had never happen before, occurred again on 10/3/2009. Emergency room, doctor ran EKG and ECO showed nothing. 10/28/2009 records from Cardiologist and PCP for dates 9/22/2009 and 10/13/2009. Patient presented with sx of syncope, incoherent speech, paleness, and "passing out" while running a marathon on 9/19/2009. Cardiac workup was negative. Patient saw new PCP 10/13/2009, asymptomatic at this time. Further dx tests were ordered.

VAERS ID:359264 (history)  Vaccinated:2009-09-30
Age:4.0  Onset:2009-10-02, Days after vaccination: 2
Gender:Female  Submitted:2009-10-04, Days after onset: 2
Location:Georga  Entered:2009-10-04
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
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B116BA0IMRA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT3178EA0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0715Y2SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1047Y1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: REDNESS IN RT UPPER ARM 3IN.DIAMETER/SLIGHTLY WARM/2" LONG/PUFFY

VAERS ID:359265 (history)  Vaccinated:2009-10-02
Age:33.0  Onset:2009-10-03, Days after vaccination: 1
Gender:Male  Submitted:2009-10-04, Days after onset: 1
Location:Ohio  Entered:2009-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2192IMLA
Administered by: Military     Purchased by: Military
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: Site of anthrax injection is red, swollen, painfull and warm to the touch

VAERS ID:359267 (history)  Vaccinated:2009-10-02
Age:77.0  Onset:2009-10-02, Days after vaccination: 0
Gender:Female  Submitted:2009-10-04, Days after onset: 2
Location:Washington  Entered:2009-10-04
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS90658  RA
Administered by: Unknown     Purchased by: Public
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Soreness, heat in arm, swelling,unable to raise arm. Swelling has continued to 10/04/2009 along with redness and soreness. Not as sore as Friday-able t raise arm Sunday.

VAERS ID:359268 (history)  Vaccinated:2009-08-25
Age:29.0  Onset:2009-09-25, Days after vaccination: 31
Gender:Female  Submitted:2009-10-02, Days after onset: 7
Location:Indiana  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins (Potassium iodide + Potassium sulphate + Calcium salt + Phosphorus salt + Vitamin A + Ascorbic acid + Niacinamide + Thiamine hydrochloride + Riboflavine + Vitamin D + Manganese salt + Iron salt + Cobalt sulphate + Magnesiu
Current Illness: Unknown
Preexisting Conditions: Bactrim Allergy; The subject had not previously received influenza vaccine. She had not experienced adverse events following previous vaccinations.
Diagnostic Lab Data: 25 September 2009: Ultrasound revealed the subject had miscarried twins at approximately 8 weeks.
CDC 'Split Type': A0809839A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA259AA UNUN
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan abnormal, Uterine dilation and curettage
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This case was reported by a consumer (also the subject) and described the occurrence of miscarriage in a 29-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included Bactrim allergy of rash or hives. The subject had not previously received influenza vaccine. She had not experienced adverse events following previous vaccinations. Concurrent medications included Prenatal vitamins. On 25 August 2009 at 10:00 the subject received 1st dose of FLULAVAL (0.5 ml, unknown route) when she was 8 weeks pregnant. On 25 September 2009, 31 days after vaccination with FLULAVAL, the subject experienced miscarriage. The subject went for a routine check up on 25 September 2009 and no heart beat could be found. Ultrasound determined that the subject had miscarried twins at approximately 8 weeks. This case was assessed as medically serious by GSK. The subject was treated with dilatation and curettage as a same day surgical procedure at the hospital.

VAERS ID:359269 (history)  Vaccinated:2009-08-27
Age:0.5  Onset:2009-08-31, Days after vaccination: 4
Gender:Male  Submitted:2009-10-02, Days after onset: 32
Location:Foreign  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE
Current Illness: Unknown
Preexisting Conditions: First dose of INFANRIXQUINTA administered on 22 June 2009 was followed by lower limbs edema and erythema, hypotonia and unusual crying. Second dose of INFANRIXTETRA administered on 21 July 2009 was well tolerated, ACTHIB was administered on 28 July 2009.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0584087B
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 2IM 
Administered by: Other     Purchased by: Other
Symptoms: Crying, Cyanosis, Erythema, Oedema peripheral, Vaccine positive rechallenge
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: This case was reported by the regulatory authority (numbers TS20090399 and 09 421) and described the occurrence of lower limb cyanosis in a 6-month-old male subject who was vaccinated with INFANRIXTETRA (GlaxoSmithKline). This case was linked to case B05840878 (same subject, same events). On 18 June 2009, the subject received a first dose of INFANRIXQUINTA and presented with erythematous edema on both lower limbs with cyanosis, unusual crying and hypotonia (see case B0584087A for more details). On 21 July 2009, the subject received his second dose of INFANRIXTETRA (GlaxoSmithKline), without a problem. On 28 July 2009, he received one dose of ACTHIB (non GSK) without problem. On 27 August 2009, the subject received the third dose of INFANRIXTETRA in one lower limb (intramuscular, batch and injection site unknown) with administration of DOLIPRANE during 48 hours. There was no immediate adverse effects. On 31 August 2009, four days after vaccination, the subject presented with unusual crying, erythematous edema of both lower limbs with cyanosis (positive rechallenge), leading to hospitalisation during several hours in the emergency unit. All the events resolved within several hours. Events did not reoccur during the following days. The agency considered the events as possibly related to vaccination with INFANRIXTETRA and dubiously related to paracetamol, according to the method of imputability. Case closed; no more information will be available.

VAERS ID:359270 (history)  Vaccinated:2009-08-31
Age:0.3  Onset:2009-08-31, Days after vaccination: 0
Gender:Unknown  Submitted:2009-10-02, Days after onset: 32
Location:Foreign  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 31Aug2009, 38deg C
CDC 'Split Type': B0595477A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20907005 IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA72CA411A SCUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERB0354 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Cyanosis, Heart rate increased, Hypotonic-hyporesponsive episode, Pallor, Pyrexia, Somnolence, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: This case was reported by a regulatory authority (PL-URPL-OCR-2009-0929002) and described the occurrence of hypotonic-hyporesponsive episode in a 3-month-old subject of unspecified gender who was vaccinated with HIBERIX (GlaxoSmithKline), DTP vaccine and IMOVAX POLIO (non-gsk). On 31 August 2009 the subject received unspecified dose of HIBERIX (subcutaneous), unspecified dose of DTP vaccine (intramuscular), unspecified dose of IMOVAX POLIO (intramuscular). On 31 August 2009, within hours of vaccination with DTP vaccine, HIBERIX and IMOVAX POLIO, the subject experienced hypotonic-hyporesponsive episode. When the subject woke up, the baby presented pallor, lip cyanosis and sleepiness which did not withdraw. The subject visited the physician. At examination the subject had tachycardia, pallor, and lip cyanosis. The subject was hospitalized presenting fever 38 deg C (duration of 1 day) and increased frequency of heart rhythm. Medical test excluded an infection. At the time of reporting the events were resolved. No further information was available as this was all the information that regulatory authorities had.

VAERS ID:359271 (history)  Vaccinated:2009-03-03
Age:0.4  Onset:2009-03-03, Days after vaccination: 0
Gender:Male  Submitted:2009-10-02, Days after onset: 212
Location:Foreign  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, Mar2009, 201; Alkaline phophatase normal, Mar2009, 303; Amylase, Mar2009, 23; Base excess, 2009, -6.6; Bilirubin, Mar2009, 9mmol/l; Blood count, Mar2009, viral infect; Body temperature, 05Mar2009, 39deg; C-reactive
CDC 'Split Type': B0595613A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Base excess decreased, Blood alkaline phosphatase normal, Blood amylase, Blood bilirubin normal, Blood count abnormal, Blood potassium normal, Blood sodium decreased, Body temperature increased, C-reactive protein increased, Diarrhoea, Gamma-glutamyltransferase increased, Gastroenteritis rotavirus, Haemoglobin increased, Hyponatraemia, Lymphocyte count increased, Monocyte count increased, Platelet count normal, Pyrexia, Rotavirus test positive, Transaminases increased, Urine analysis normal, Vomiting, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a regulatory authority (# 916/2009, 917/2009) and described the occurrence of elevated serum transaminases in a 4 month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX; GlaxoSmithKline; oral given on 2 January 2009. On 2 January 2009 and on 3 March 2009 the subject received 1st and 2nd dose of ROTARIX (oral) batch number unknown. On 05 March 2009, 2 days after vaccination with 2nd dose of ROTARIX, the subject experienced fever 39 deg C which continued for 2 days. Therefore he was hospitalized from 05 March 2009 to 06 March 2009. Relevant test results included elevated serum transaminases 201, normal alkaline phosphatase 303, normal amylase 23 (normal bilirubine 9 mmol/l) and glutamyltransferase 42. Blood test count showed viral infection, thrombocytes 336, c-reactive protein repeatedly below 5, hemoglobin 116, leucocytes 4.2-3.2, differential count neutrocytes 32, lymphocytes 48 and monocytes 16%. Sodium was quite low 134-132 and potassium 4.6. Chemical screening of urine and biopsy were negative. At the beginning of June 2009, the lab test results were normalized. On 30 June 2009 the subject was re-hospitalized due to vomiting and watery diarrhea which became more intense. The child was hospitalized in order to correct fluid balance and hyponatremia. The diagnosis was rotavirus gastroenteritis. The subject was treated at the beginning with intense oral fluid and after intravenous rehydration was given. During the second day the symptoms started to disappear and the subject was monitored until stool became solid. On 03 July 2009 the subject was discharged in good clinical conditions. Relevant test included C-reactive protein 32, in astrup method BE -6.6, sodium 133, potassium, 4 and stool sample revealed Rotavirus.

VAERS ID:359272 (history)  Vaccinated:2009-09-15
Age:33.0  Onset:2009-09-26, Days after vaccination: 11
Gender:Female  Submitted:2009-10-01, Days after onset: 5
Location:Unknown  Entered:2009-10-02, 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: Vancomycin; ZOSYN; Azithromycin; FLAGYL
Current Illness: Pregnancy
Preexisting Conditions: 10/20/09-records received-PMH: depression. Anorexia in teen, mood disturbances, anxiety. Miscarriage. Elective termination of pregnancy. PMH: Anxiety, depression. Vaccine exposure during pregnancy. Allergies: NKDA
Diagnostic Lab Data: ARDS 10/20/09-records received-WBC 21,000, hemoglobin 8.5, hematocrit 25, mononucleosis negative, serum actone level positive, ESR 41, protein C125 cortisollevels 69 low adrenal insufficiency, EDD 11/2/09 34 weeks gestation LP increased protein. Labs: VDRL, RPR non-reactive, FV Leiden neg, C3 low, Streptococcal antigen neg, RHI viral testing neg, CBC: WBC hugh, Hgb and Hct low, Platelets high, Bands high, Neutrophils high, Rbc morphology abnormal, Serun acetone +, Blood ,urine and stool cultures neg, CSF Protein 114 high, CSF culture neg, CMV neg, Neutrophil Cytoplasmic antibody neg, Anticardiolipin profile neg, BMP: Na low, K and LDH high, Urine ketones high, Bronchial washing gm + cocci,urine drug screen + for benzodiazepines Dx studies
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3184AA IJUN
Administered by: Private     Purchased by: Unknown
Symptoms: Abdomen scan normal, Acute respiratory distress syndrome, Adrenal insufficiency, Apgar score normal, Asthenia, Back pain, Band neutrophil count increased, Blood cortisol decreased, Blood culture negative, Blood gases abnormal, Blood lactate dehydrogenase increased, Blood pH increased, Blood product transfusion, CSF culture negative, CSF protein increased, Caesarean section, Cardiolipin antibody negative, Chest X-ray abnormal, Complement factor C3 decreased, Computerised tomogram abnormal, Contusion, Culture stool negative, Culture urine negative, Cytomegalovirus test negative, Demyelinating polyneuropathy, Drug exposure during pregnancy, Drug screen positive, Dysaesthesia, Dysgeusia, Dyspnoea, Electrolyte imbalance, Electromyogram abnormal, Endotracheal intubation, Facial paresis, Fatigue, Flank pain, Foetal heart rate deceleration, Guillain-Barre syndrome, Haematocrit decreased, Haemoglobin decreased, Headache, Hyperhidrosis, Hyperkalaemia, Hypoaesthesia, Hypoaesthesia facial, Hyponatraemia, Lethargy, Lumbar puncture abnormal, Metabolic acidosis, Nausea, Neutrophil count increased, Nuclear magnetic resonance imaging brain normal, Oxygen saturation decreased, Paraesthesia, Peripheral sensorimotor neuropathy, Plasmapheresis, Platelet count increased, Protein C, Red blood cell abnormality, Red blood cell sedimentation rate increased, Reflex test abnormal, Respiratory distress, Respiratory failure, Sensory disturbance, Streptococcus identification test negative, Syphilis test negative, Ultrasound Doppler normal, Ultrasound abdomen normal, Urinary incontinence, Urine ketone body present, Viral test negative, Vision blurred, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Congenital and neonatal arrhythmias (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug abuse and dependence (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Glaucoma (broad), Cardiomyopathy (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad)
Write-up: Positive vomiting, nausea, back pain, evanescent dysesthesias, positive blurry vision, shortness of breath and facial weakness - Tx. Plasmapheresis - 9/30, 10/1.10/20/09-records received for dates of service 9/27/28/09C/O numbness in face, arms, back and belly, vomiting, headache, blurry vision and shortness of breath along with decreased taste, diaphoresis. 9/28/09 worsening numbness, continued nausea and vomiting, left flank pain, severe fatigue. Consultation, continues with facial weakness and respiratory distress, and desaturation to 78%,intubated with abnormal arterial blood gas pH of 7.11, and respiratory failure, hyponatremia and hyperkalemia, multiple electrolyte abnormalities, new onset of bruising. 10/29/2009 Consult records and Lab and Dx studies from Inpatient stay 9/27/2009-10/16/2009. Patient with c/o''s facial numbness, tingling in extremities, Neuro exam noted dec DTR''s, dec sensation pinprick, temperature. EMG anormal with Dx of GBS. Tx: intubated for resp distress, IVF, IV ABX, C-section done. 12/09/09 DC summary for DOS 09/27/09 - 10/16/09. Final DX: GBS. Pt c/o generalized weakness, back pain, L flank pain, chest pain, SOB, changes in taste and sensation, diaphoresis, headaches, insomnia, facial weakness. On examination: Pt lethargic, worsening of weakness, lost bladder function. On 09/29/09, Pt tachypneic, SOB, anxiety, low oxygen saturation. Emergent intubation initiated. Pt transferred to ICU. Pt developed metabolic acidosis with hyponatremia and hyperkalemia. On the same date, Pt underwent an emergent C section due to decelerating fetal heart beat and delivered a viable baby. Tx: plasmapheresis. Pt''s respiratory status and weakness improved. Pt discharged to a rehab center. ICD-9 codes: 648.91, 518.81, 357.0, 358.0, 507, 446.6, 276.7, 276.1, 276.2, 788.30, 648.41, 670.22, 300.4, 296.90, 306.9, 659.71, 647.91, v270, v025.1, 356.9

VAERS ID:359273 (history)  Vaccinated:2009-09-02
Age:10.0  Onset:2009-09-23, Days after vaccination: 21
Gender:Male  Submitted:2009-10-02, Days after onset: 9
Location:Connecticut  Entered:2009-10-02
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: Asthma. 11/17/09 ED, hospital records, hospital and rehab discharge summaries received service dates 9/24/09 to 10/26/09. Asthma, febrile seizures, RSV. Bee sting - anaphylaxis. Sulfa drugs - rash.
Diagnostic Lab Data: Lumbar puncture; Nerve conduction test (+); increased protein. 11/17/09 ED, hospital records, hospital and rehab discharge summaries received service dates 9/24/09 to 10/26/09. LABS and DIAGNOSTICS: CSF - RBC 7 (H) WBC 1 cells/uL Glucose 64 mg/dl Protein 124 mg/dl (H). CBC - WBC 9.1 10^9L Platelets 613 10^9L (H) HGB 14.6 g/dl HCT 42.2% Gran 66%. CHEM - Calcium 9.9 mg/dl CK 29 U/L (L) Cl 99 mEq/L Bicarb 26 mEq/L Creatine 0.4 mg/dl Glucose 99 mg/dl Potassium 4 mEq/L Magnesium 2.1 mEq/L (L) Sodium 136 mEq/L Phosphorus 4.8 mg/dl. EMG - Abnormal, consistent with Guillain-Barre.
CDC 'Split Type': CT200914
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3259EA5IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Abasia, Ataxia, Back pain, Blood albumin decreased, Blood creatine phosphokinase decreased, Blood glucose increased, Blood magnesium decreased, Blood product transfusion, Breath sounds abnormal, Bronchitis, Bronchospasm, CSF protein increased, CSF white blood cell count, Cough, Dizziness, Ear infection, Electromyogram abnormal, Exercise tolerance decreased, Eyelid ptosis, Facial asymmetry, Facial palsy, Gait disturbance, Granulocyte count increased, Guillain-Barre syndrome, Headache, Hyporeflexia, Influenza like illness, Lumbar puncture, Lymphocyte percentage decreased, Malaise, Mean platelet volume decreased, Muscular weakness, Nausea, Neck pain, Nerve conduction studies abnormal, Otitis media, Pain, Pain in extremity, Platelet count increased, Rales, Red blood cells CSF positive, Vomiting, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Myelodysplastic syndrome (broad)
Write-up: Neck pain, leg weakness, (R) arm pain, ataxic gait, worsening over 2 days. -$g Bell''s palsy. 11/17/09 ED, hospital records, hospital and rehab discharge summaries received service dates 9/24/09 to 10/26/09. Assessment: Guillain-Barre Syndrome Patient with URI symptoms onset 1 week ago, seen by PCP for otitis, followed by malaise, cough, nausea, vomiting. Lower extremity ataxia and numbness, right upper arm pain. Ataxic gait, right sided facial droop and ptosis. Weak patellar reflexes bilaterally. Pain with downward gaze. Headache. Generalized back pain over spine on palpation. Unable to walk. IVIG administration. Discharged - to continue outpatient OT/PT.

VAERS ID:359274 (history)  Vaccinated:2009-10-01
Age:22.0  Onset:2009-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-10-02, Days after onset: 1
Location:Alabama  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN; AMOXIL; ZOLOFT
Current Illness: Group A strep
Preexisting Conditions: Depression
Diagnostic Lab Data: Dx strep on 9/23-completed AMOXIL on 10-1
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA262AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Pruritus, Rash macular, Skin burning sensation, Streptococcal infection
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Late PM after receiving injection around 11:45 AM of the same day, hands itching/red/burning/rash-macular. Woke at 4 AM with burning/itching-No meds to tx-Returned to clinic at 8 AM given ZYRTEC 10 mg, TRIAMCINOLOE 0.1% cream to use BID.

VAERS ID:359275 (history)  Vaccinated:2009-09-14
Age:13.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-10-02, Days after onset: 18
Location:Texas  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: 9-14-09 Upper Respiratory Infection
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1604X1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Feeling hot, Oedema peripheral, Tenderness, Upper respiratory tract infection, Vein disorder
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Entire arm had swelling to R arm, R tender to touch, and veins were bulging on arm, and it was hot to touch and when pt bumps her arm, she experiences tenderness and swelling to entire R arm, no color change. Swollen more on Rt arm and upper half Rt forearm. No fever, no headaches, had URI x5 d, took TYLENOL only Loratadine given that day.

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