Reporting vaccine reactions to VAERS is the law.
Note: For help, consult the US NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (“DAIDS AE grading table”). This table contains descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. (download grading table HERE).
Review or Search Recent Vaccine Reactions Reported from Vermont
2013: click here for full report
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Age: 1 year. Vaccines: HepA, MMR, Varicella: “8 dys after 12 month imms. pt experienced high fever (104 degrees) and seizure, with respiratory distress. Due to respiratory distress pt. intubated and hospitalized. The following information was obtained through follow-up and/or provided by the government. 6/26 & 27/2013 ER records received for DOS 6/11/2013. Transfer Dx: respiratory arrest. Pt c/o fever, vomiting, & lethargy followed by altered mental status, poor color, jerking movements. EMS activated, transported to ER. PE: limp, cyanotic, O2 sat 40s (L), lethargic, shallow respirations, severe rhonchi. URI symptoms (runny nose, cough) for 1 wk prior to event. Pt intubated, transferred in critical condition for higher level care. 6/26 & 7/11/2013 hospital records received for DOS 6/11-13/2013. D/c Dx: complex febrile seizure. Pt admitted w/ above hx. Tx”t: IVF, mechanical ventilation, anticonvulsant, ABX, PICU, foley. Successfully extubated 6/12. No further evidence of seizure activity. Pt d/c”d home in good, stable, improved condition w/ care & f/u instructions.”
Epilepsy after vaccination in a Two-Year Old:
Vaccine reactions reported in Vermont 2012:
Source: http://vaers.hhs.gov/index ~ Are they truly all just “COINCIDENTAL?”
• Patient woke from her nap crankier than normal; within an hour, she was screaming inconsolably. Her legs became red and swollen at each vaccination site. She seemed to be running a slight fever, but nothing over 101F. At our pediatrician’s advice, we gave her a dose of infant Tylenol, and applied cold compresses to the vaccination sites; this eased her discomfort. We needed to repeat the Tylenol at two more doses to keep her from becoming extremely upset at those times; irritability continued for about 36 hours after the vaccination.
• Patient became unusually fussy and could not be consoled easily. Wasn’t nursing well. Fell asleep around 10pm and woke up around 1am with 101-102 fever. Treated with infant ibuprofen. Fever went down to 99-100. Fever/treatment continued for next day. That evening (12/29) noticed three areas of red blood in stool. Called PCP and was told it was likely an anal tear. Patient is breastfed so no straining to have movement, and movements had been normal. Continued fussy for next day. On 1/1 developed dry cough and some chest congestion. Eating normally, and having regular wet/soiled diapers. Was not ill prior to shots (Prevnar 13 and Hib), does not attend daycare and has not been exposed to sick people.
• Vomiting, diarrhea, fever, chills, aches, exhaustion.
• Pt received MMR and Varicella vaccine 5/9/11, developed a fever 5/12/11 102.7, had 2 seizures, one last 10 minutes the other 7 minutes. Taken to nearest ER via rescue.
• Slight rash that turned into fever. As days went by rash got worse. All over back, stomach, face and was spreading to limbs. Puffy and swollen eyes.
• Redness and red spots on (R) thigh 7 days after immunization (also some induration).
• Rash on trunk area – not pustular – rash began 1 wk after vaccine. 1 wk prior to rash -> cold sxs. Area with pale purplish red urticaria on (R) thigh (injection site) approx 3 cm diameter.
• Child vomited. Fever 101 to 103 degrees lasting 24 hours. Children’s Tylenol 1.5 ML every 4 hours to control fever.
• Large red reaction surrounding injection site, swelling of upper arm.
• Mother reports 8 hrs. following immunizations that pt. was sleepy with rolling eyes and sticking her tongue out, along with fever. The next night pt. had leg up in the air and mother had difficult time pulling it down. (Mother did give Acetaminophen the first night).
• Pt c/o temp and joint aches after Influenza vaccine – Mom request report be made.
• DTaP/IPV and VARIVAX given at 14:30 on 2/7/11 as health care maintenance. Patient found unresponsive with vomit in bed around 6 am on 2/8/11. Pronounced deceased on arrival to the ED on 2/8/11. Presumed cause of death is status epilepticus in this patient with known and worsening epilepsy. Medical Examiner involved, and no autopsy performed.
• Swelling 10 x 8cm (L) deltoid with erythema. (L) axillary node 3 x 5 cm.
• See attached. I saw her 10/10/11 when her sister was in. Still has a 6cm x 4cm bruise. It doesn’t hurt, but it is hard to tell which vaccine. Looks like MMR. I spoke with mom and she said it was her left arm. Unaware which vaccine it was. She couldn’t tell me if it was deltoid or back of her arm. But she says its about the size of patient’s hand, and hot to the touch. A little bruising. I told her ice and MOTRIN, she said she only had TYLENOL and I said that was fine but it may not work as well. She could have 2 tsp of childrens. I told her to draw a circle around it and to call back in the am and tell us how much bigger it spreads. If it gets too large and she is worried I said nurse is on call and she will talk to her. If it gets too big we need to see her and do a VAERS report. She is still able to move her arm fine, she just doesn’t like people touching it.
• Erythema nodosum, myalgia, arthralgias started 48 hours after immunization.
• 10 days after vaccine developed fever 0f 101-102. Swollen glands at neck – achey joints.
• Went for well child check 12/2 no issues flu vaccination given. Next day developed flu like illness with fever 102.3, body aches lethargy, treated with Tylenol and Motrin, symptoms waxed and waned got significantly worse Tuesday 12/6/11 with dyspnea. Patient went unresponsive on way to pediatrician emergent resuscitation and died 12/6/11.
• Pt came in with urticaria one week after shots.
• Dec 3 & 4-felt tired, slight cough, dizzy. Dec. 5-fever 103 F, productive cough. Dec. 6-MD diagnosed pneumonitis Dec. 9-chest x-ray RLL pneumonia
• 5/2/11 Phone call from mom stating “bug bite” looking rash all over body. Not ill. No fever. Probably, per mom, related to old sunscreen.
• Redness and swelling at the injection site, not warm or painful. Increased over the next 24h
• Resp. arrest after exposure to “fog machine” at school dance, then cold air – occurred within 6 hours after immunization. H/O bad asthma.
• Had below imms on 11/15/11. That eve – red, itchy rash bil hands. Then chest tight. Took to ER – given BENADRYL. They thought possibly viral. Slept well. Next AM SOB, chest tight, no feeling (R) hand. Rash continues. On BENADRYL and her albuterol (has asthma). Site of injection WNL, no erythema, no edema.
• 18 yo female previously not vaccinated, needed immuniz. for college, came into office and had Tdap, Hep B, MENACTRA and MMR administered (6/29/11). A few days later developed body aches and a fever at aprox 10d. after immunizations developed a head to toe rash which is itchy. No tongue/lip swelling, no wheezing/anaphylaxis symptoms.
• Erythema 7.5 x 5 cm with induration at injection site.
• Vertigo, pale, headache.
• Pain and stiffness in arm around injection site, starting a few hours after injection. Stiffness in back, legs, arms (increasing at injection site), pain in calves apx 12 hours after injection. Fever starting apx 20 hours after injection. Restlessness, insomnia (mostly from feeling so uncomfortable) general listlessness, nausea starting this morning (Sunday) productive cough (clear white mucus).
• #2 Varicella injection given 9/13/11 in left upper arm. Pt received #1/2 on 8/15/11 w/o reaction. Presented with 10cm erythematous single welt like lesion positive tender. Local reaction vs cellulitis.
• TDAP administered subcutaneously on 11-16-2011. Site evaluated 11-19-2011 in follow-up and no problems noted. Pt contacted 12-2-2011 in follow-up, she reports no long-term effects.
• Pt developed severe pain 10/10 and swelling at injection site, pt states pain started soon after injection and got much worse from day of injection. Pt given Methylprednisolone Pak and TYLENOL #3.
• I received the Flu Vaccine yesterday. In the middle of the night I woke up with a fever, chills, shortness of breath, body aches, headache, and uncontrollable shaking. This lasted for one hour. This morning I still have a fever.
• Swelling and erythema to arm from 2″ above elbow extending to upper arm, shoulder, and anterior axilla. Painful. Pt reported itching, red rash about 8 hrs. after injection. Prednisone burst x 1 wk. (20mg BID x 7 days).
• pain, redness, extensive swelling and feels like a hard bunch right near where the Tdap shot was given on my arm and its still there
• C/O deltoid muscle sore, swollen, inflamed – unable to abduct arm for 1 week. Also had spasms in left arm once it started to move normally.
• Patient says injection administered too high and she believes the bursa. She now has bursitis that won’t resolve. Patient states may need cortisone injection to resolve.
• This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline) while pregnant. Concurrent vaccination included ADACEL (Sanofi Pasteur) and PPD given 12 May 2011. On 12 May 2011 at 09:30 and 12 April 2011 at 14:00 the subject received 2nd dose and 1st dose of TWINRIX adult (1 ml, unknown, left deltoid). The subject experienced vaccine exposure during pregnancy. It was reported that the subject visited the emergency room presenting with pelvic pain, but was not admitted to the hospital. At that time, it was determined that the subject was 6 weeks pregnant. Her date of last menstrual period and estimated date of delivery were not known. The pregnancy was ongoing at the time of reporting.
• One day after vaccine administration, pt began feeling nausea/vomiting/diarrhea. Two days after vaccine administration, patient spiked a fever, swollen neck. Went to her PCP on 4/6/11 and was diagnosed with the mumps.
• Lightheadedness, with seizure like symptoms, then fainting, lasted approx 10 sec 911 called; I laid her down on floor with feet raised, the 911 techs took over, ambulance & tech took her from store.
• 24 hours after the vaccine was administered, patient developed a low grade fever and sore arm. She took Advil. At 3:30 pm she spiked a fever and had chills. 6:30 pm her heart was racing, temp 103.5. She called her MD on call. He recommended Benadryl (patient did not have any) and cold compresses. 8:30 pm Temp 102. 11-11-11 2 Am Had chills and temp 102. Took Tylenol. Woke in am with achiness and continued painful right arm. Temp now gone but arm painful with resistence. She said the arm does not have redness or swelling but there is a bruise. She said it does not appear infected. I recommended she follow up with her provider if the arm does not improve and could try warm compresses or ice (which ever felt better to her to help decrease the pain. On a scale of 1-10, at it’s worst the pain was a 7 and now is a 2.
• Redness & swelling in (R) arm within hours of shot – Temp 102, chills, tremors, fatigue, diarrhea redness and swelling from (R) axilla to mid forearm treated with KEFLEX and antihistamine.
• Pt developed a red blister over area of injection the next day. Pt states it popped and left a gaping hole. On exam today, area of slight erosion & scarring. Mild tenderness at site of injection. No treatment.
• Injection site tenderness & swelling – muscle ache affected arm – erythema.
• Left deltoid reddened, tender and slightly swollen Pt. reports worsened overnight. Erythema to upper left arm that extends to inner aspect arm halfway toward elbow. Advised to elevate and take ibuprofen for pain.
• Had uncontrollable violent shaking for about an hour, then fever and chills all night and the next day with vomiting. Missed 2 days of work.
• I became achy and feverish flu like sysmptoms. Apporx 9:30pm at my residents Ibegan to experince chills, Fever, soreness and dizziness. Approx. 11:30pm I was experincing an extremely high temp. (106*)severe chills, dizziness, disorientation, rapid heart beat and vomiting. Throughout time line I was drinking water and taking 800ml of Ibuprofen. Approx 1:30am on 10/18/11 my Fever and symptoms started to reside. Temp dropped (104*) chills started to subside and Vomiting stopped. Approx 3:00am body temp was down (101*) chills almost gone and hot burning sensation disappeared too. Approx. 5:45am awoke after a couple of hours of sound sleep. Except for light headedness and feeling of being tired all sysmptoms had gone. Approx 7:00am on 10/18/11 I had only a bad headache and nasal stuffiness type feeling left. Approx 9:00am I called my Doctor reported reaction event and was advised to continue Tylenol or Ibuprofen. Approx 5:30pm on 10/18/11 all symptoms gone. Felt fine.
• 6 days after vaccine patient developed fever, chills, vomiting & diarrhea.
• Acute hepatic failure, question etiology, r/o relationship to recent Hepatitis A and Hepatits B vaccinations.
• Pt c/o chills, body aches, swelling at injection site – erythema.
• Red blotchy area on upper arm where injection was given with slight swelling.
• Half moon rash (bumps) at injection site moving up arm to shoulder.
• This case was reported by a healthcare professional and described the occurrence of lightheadedness in a 57-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) for pre-employment physical. On 19 August 2010 at 13:30 the subject received 1st dose of ENGERIX B (standard dose, unknown route, left arm). On 19 August 2010, 1 hour after vaccination with ENGERIX B, the subject experienced lightheadedness, dizziness and intermittent blurred vision. .The physician who discharged her noted nothing unusual. On 19 August 2010, the events were resolved.
• Left arm where pt. received Tdap on 8/2/11 is red, swollen, warm to touch with hard middle. Area of redness 7cm W x 5cm high on (L) deltoid. Pt has applied ice & has taken TYLENOL.
• Patient has redness, itching at site of injection, saucer size, still evident on 11/2/11.
• Patient reported an egg size & shape red area at site of injection that itched for several days after injection.
• Noticed on 9/17/11 (R) arm itchy, red, swollen. No c/o pain.
• Arm pain, fever, nausea, vomiting, chills
• Pt. called 2 days after immunization to say she had stiff neck, throat felt swollen on left side, gland felt swollen, & pt. had tingling in fingers left hand, with numbness in one finger. Pt. was advised to use pain reliever and to schedule office visit if no improvement by next day.
• Swelling 3 1/2 round. Red warm to touch.
• Extreme muscle soreness on Right arm w/in min of rec. Pain spread to shoulder, neck, chest, back by mid-afternoon. Resolved after 9 days.
• Red, swollen and warm area approximately 4″ in diameter around the site of injection.
• Swelling, warmth, tenderness, erythema spreading from site over the next several days, fevers and rigors.
• Pain in movement of arm, frozen shoulder, difficulty moving arm and lifting items. Pain continues after 4+ weeks with no improvement.
• None stated.
• Arm swelling, pain, redness w/edema down arm.
• Left arm swelling to 2.5 times into collar bone. Hot to touch, redness, skin hard as rock, skin painful in certain spots especially at injection site. Pain in muscles across chest to bridge of shoulder. Called doctor this morning told to ice area and take acetaminophen as needed however already takes this medication 6 times a day for leg pain. Swelling has gone down a bit in some areas, worse at upper part of arm. Bicep as large as a body builder. Barely can sleep, can’t move shoulder much, can’t lie on it either, not even sleep on back since shoulder falls back. Last pneumonia vaccine received 10 years ago.
• I got my Flu shot around 3 in the afternoon on Sept 16th, and was in our local ER bleeding from my lung that night. Doc’s at hospital (was shipped via ambulance from our local hospital) came in next day telling me my WHITE BLOOD CELL COUNT WAS LOW AND CONCERNED THEM (I highlighted in Red the first ‘reaction’ shown in the box below)…So for a short ‘window of time’ after the Flu shot (approx. 24 hours all told), these things happened. Thrombocytopenia (abnormally low platelet count, which can result in abnormal bleeding) My note: this is what happened to me after getting Flu shot earlier in the day…I had a LOW white cell count that concerned Docs the following day! And was bleeding from my left lung! One of the Serious adverse events in your package insert. I definitely will never get another Flu shot of any kind for any reason. I was NOT informed that the shot I was getting was 4 times the amount of flu bug as the regular shots…I feel like a guinea pig being used for experimentation without my knowledge or consent! Apparently the injection set my white cells on the attack due to your products invasion, and I could not produce them fast enough, resulting in the LOW cell count, resulting in the bleeding…
• Started 11/14 with numbness and Tingling in toes and fingers. Progressed to waist and then on Saturday, Nov 12, developed a Bell’s Palsy and ataxia.
• Left lumbar left leg radicular pain.
• Received shot high on arm. Has pain in left arm and has difficulty in moving arm without pain. Has been to neurologist and had physical therapy for past 3 weeks. Slight improvement.
• Pt complaining of left arm pain, & can’t lift the arm up.
• Patient developed itching and hives initially only at injection site which resolved but several days later, itching and hives appeared over various parts of body.
• 24 hrs after Inj. redness & pain (L) upper extremity, continue to worsen over the week. 2 sites, one inferior to inj site 6cm in diameter & tender. Distally, 10cm area warm, tender, & redder. Treated with KEFLEX 500mg Tid.
• Date of vaccine 7/19/11 – Temp 102, headache between eyes (like flu), chills, TB skin test at same. On 7/23 broke out hives all over except face. Taking BENADRYL. Hives get worse 5:30-6:00 pm, then BENADRYL helps lower hives. Cheeks get bright red – ZYRTEC started 8/15.
• After check-out I was looking over the sales slip and re-arranging items in cart. I took one step backwards and tripped over the “barrier” cone in front of the customer service desk. I fell over backwards, landing on right buttocks and head. It’s possible that I fell as result of dizziness from the vaccine shot, but more likely that I was simply not watching my step. I’m in good physical shape and in fact just before the vaccine I participated in an aerobics class. Alerted doctor’s office and advised to use ice on buttock injury.
• Felt tired & weak for a few days headache, tender throat, discomfort swallowing (L) side of neck has swollen lymph node.
• Patient complained the following [[name]] she got the shot saying her arm is itching and red. I counseled her to apply BENADRYL/ZNO cream but she didn’t feel well the 2nd [[name]]. Visited her PCP who diagnosed her with cellulitis and allergic skin reaction followed vaccine. Treated with CIPRO 500 mg tab for 1 week and fluconazole 150 for 1 [[name]].
• I am requesting that your office file this Vaccine Adverse Event Report. Here is my experience regarding Tdap vaccine. Prior tetanus shots (alone and with other vaccines) in the military and locally provided no adverse reactions. 10/27 9:30am. Vaccine administered. 12 noon Had lunch. 2pm Felt tightness in upper digestive tract. 5pm Could not eat supper. Upper tract still blocking digestion. 6pm Went to bed. Slept the night with poor digestion. Had chills and then fever. Did not take temperature. 10/28 Stayed in bed all day and night. Had continuing diarrhea and headache. Very tired not wanting to accomplish anything. No pains or redness at site of vaccination. 10/29 Continuing diarrhea. No headache. Tired, not wanting to accomplish anything. 10/30 Better, still some stomach discomfort. I have checked all symptoms experienced on the yellow sheet attached. This was supposed to be just a tetanus booster. I accepted that Tdap was appropriate. My concern is that this process was just part of a trial for the combined vaccine. Why would it be administered to a 76 year old? Your feedback will be appreciated and that the report was filed. 10/31/11 Call placed to pt, pt feeling better. He would like his symptoms reported.
• Information has been received form an 81 year old male patient with high blood pressure, who in September 2009 was vaccinated with ZOSTAVAX. Concomitant therapy included ibuprofen, ENAPRIL and “nurton”. In October 2009, the patient experience shingles. The patient reported he had broken out with shingles twice. At the time of the report, the patient’s out come was unknown. The patient sought unspecified medical attention. Unspecified labs diagnostic studies were performed. Additional information has been requested.
• Hives on legs & arms that is “really itchy”.
• Received HiB #4, PREVNAR #4, Varicella #1 and MMR #1 on 02/14/11 / on 02-24-11 pt. had a rash – (see attached note).