You may have never heard of VAERS before. VAERS stands for Vaccine Adverse Event Reporting System. It is a passive surveillance system that collects vaccine injury reports from patients, doctors, nurses, pharmacists, and more. This is the system in place that lets us know if there is a problem with vaccines. The problem is, no one knows about it. It is estimated that only 1%-10% of vaccine injuries are actually reported. Some doctors don’t even know about VAERS.

We can change that. For one: if you or a loved one has ever been injured by a vaccine, please file a report. There is no deadline for reporting vaccine injuries, and you do not need to know the specific lot number.

If you don’t know anything about vaccine injuries, please do your homework and perform a VAERS search via CDC WONDER. Not only can anyone report a vaccine injury, but this database is open to the public. Just type in the criteria you want to look at, and scroll away.

The following is a selection of VAERS reports following Influenza Vaccination for the 2017/2018 season. My criteria selection included “serious, life-threatening events” only, from June 2017 to June 2018, for all ages, all Flu vaccines. There were 439 serious, life-threatening adverse events, which may represent as little as 1% of true vaccine injuries to the “Flu vaccine” for the 2017/2018 season.

AGE  //  ONSET INTERVAL  //  VACCINE

6-11 months	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Previously healthy child, had 4 vaccines at 10 am tomorrow and 4.5 hours later at 2:30 pm had a 5-6 minute tonic clonic seizure. Went to ER, had normal head CT without contrast, normal bone survey, all labs normal. The day of admission 5/2, child was taken to urgent care for follow-up, and started seizing. The character of the seizure as similar as previous, and lasted 5 – 6 minutes with a post-ictal period. She was subsequently transferred to hospital for admission. She was afebrile, O2 sat 99% on RA, seizure ended and no new fevers yesterday, no new seizures during admission. EEG and MRI normal; discharged with diazepam 2.5mg kit to give rectally if seizure lasts 3 minutes or longer.

6-11 months	1 day	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

2/28/2018 Per Hospital ED report-At around 2200, when parents went to wake child from nap, child was noted to appear off and parents observed generalized tremors. Pt was noted to have a fever earlier today and was given APAP at 1800. EMS stated that it lasted approximately 30 minutes. The child was not convulsing upon presentation to the emergency department but had a right gaze deviation and was rigid. 2.5 mg of rectal VALIUM and the seizure was arrested. He subsequently had another seizure and a second dose of rectal VALIUM taken the rest of the seizure. T: 37.4 degrees C (Rectal) HR: 140 (Monitored) RR: 35 BP: 89/51 SpO2: 90% WT: 8.4 kg. Patient was transferred from Hospital ED to another Hospital. Per second hospital notes-presented to first hospital with fever and seizure characterized by left arm twitch and staring, episode lasted 15 min at home and continued in EMS. Pediatric neurology recommended an EEG which was normal, patient did have another 2 seizures post EEG. Pediatric neurology recommended sending the patient home on KEPPRA 20mg/kg/day divided BID due to having 4 seizures within a 48 hour period. Patient also prescribed 2.5 mg rectal DIASTAT rescue medication for seizures greater than 3 min or greater than 3 episodes in 30 minutes. Patient was discharged home 3/2/2018 with recommendation to follow up with primary care provider in 2-3 days and Ped Neurologist in 2-3 months.

6-11 months	1 day	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

“He had a fever the night of the vaccination. His arms and legs were jerking involuntarily while he slept, often rotating one arm to the next, to the leg and so on. Prior to these vaccinations he was able to sit very well, and also would push himself up on his legs very easily while we were balancing him, and did it at every opportunity. After the vaccinations, he was unable to sit by himself without falling over, and refused to push himself up most of the time. When he did push up, his legs would buckle under him very quickly. He was crying with a very unusual high pitched cry. We took him to the emergency room in the middle of the night due to his high fever, where they assessed him as “”normal”” since his temperature went down. We were told that fevers could be caused by vaccines, but the limb flinching and muscle weakness were mostly ignored. Over the next few days we continued to monitor him, and his muscle weakness did not improve. He went from pushing himself up on his legs very easily and strongly pre-vaccination, to barely being able to hold himself up for a second, and his legs like jelly, giving way easily. The day after vaccinations, he started having long periods of staring, and not responding to anything we said or did to get his attention. We took him to the pediatrician, and on the way, we caught a video of him in one of his staring episodes, not responding to us at all. The doctor saw this video, and was concerned, so sent us to a neurologist the same day. The neurologist examined him, but he did not have any staring episodes during the examination. She considered him to be “”normal””, because she was not aware of his previous strength, and how much he had weakened post-vaccination. We were sent to pediatric neurology at the main Clinic campus to stay overnight, and have an EEG overnight. The doctors also considered him “”normal””, because they were unaware of his normal temperament and physical strength. They thought his post-vaccination weakness and temperament were simply “”normal for his age””. We were sent home, and he continued to be abnormal for about 2 weeks. Over the next couple of weeks: – he would wake up in the night screaming constantly – he continued to be very weak in his legs, refusing to push himself up where he used to do it constantly – his eyes would roll back in his head randomly, and often look very dazed – he continued to have abnormal twitching in his sleep, different from normal sleep movements – His urine and poop smelled like chemicals for 8 days – His poop was frothy and green for 14 days.”

6-11 months	6 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

The morning of Sept. 20th pt was lethargic and burning up. I rushed him to the ER were he had a fever of 105.4. Once he was stable they transferred him by ambulance to Medical Center. There he was officially diagnosed with the rhinovirus and the adenovirus. I have discovered through his medical records, he possibly may have had RSV, which we were not made aware of. While in the hospital they did an ultrasound of his kidneys and checked his uric acid levels again, now they were at a 14.9. He was released on the 21st of September, and referred to a nephrologist. On the morning of the 27th, pt was in one of his spasms which were frequent with LNS, my husband was doing routine positioning taught by pt’s physical therapist to us, to help him out of his fits. At this point, pt gasped and went limp. My husband ran into my room and we called 911. It took them 48 minutes to get pt heartbeat back, and by this point pt was brain dead. He was officially declared brain death at 1313 on September 29th. Almost instantly after arriving to the hospital, they started to accuse my husband of shaking our son. We know his is not true and believe this was cause from the brain injury due to lack of oxygen and vaccine injury.

6-11 months	6 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Initial unsolicited report received from a nurse on 10-Jan-2018. This case involves a six-month-old patient (gender not reported), who was vaccinated with first dose of 0.25 ml FLUZONE QIV via intramuscular route (batch number: UT5949KA; expiry date, route and site of administration not reported) and PEDIARIX (manufacturer: GSK) (batch number, expiry date, dose, route and site of administration not reported) and ROTAVIRUS VACCINE (batch number, expiry date, dose, route and site of administration not reported) and PNEUMOCOCCAL CONJUGATE VACCINE (PCV12) (manufacturer: Pfizer) (batch number, expiry date, dose, route and site of administration not reported) on 20-Dec-2017. Patient had a mild cough at time of vaccination. No fever. Concomitant medications were not reported. On 26-Dec-2017 in morning, six days following the vaccination, patient was found dead. Patient was previously vaccinated with all vaccines other than FLUZONE QIV twice. Lab test and corrective treatment was not reported. Reporter stated an autopsy was being performed to determine cause of death and rule out SIDS (sudden infant death syndrome). Patient’s mother felt it was the flu shot (Fluzone QIV) that caused her child’s demise. Documents held by sender: none.; Sender’s Comments: Time to onset is compatible. The patient already had mild cough at the time of vaccination. No other medical history was reported. The patient also received Pediarix and Rotavirus vaccine on the same day as Fluzone QIV. Autopsy was being performed at the time of reporting to determine the cause of death and rule out SIDS. Considering that several different vaccines had been co-administered at the same time it is difficult to elicit role of each vaccine in reported event. Result of autopsy, patient medical history, past surgical history, and state of health at the time of vaccination would be helpful with identifying role of each vaccine in reported event.; Reported Cause(s) of Death: found dead the morning; Autopsy-determined Cause(s) of Death: found dead the morning

6-11 months	6 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Patient presented to the outpatient clinic on 2/2/18 for evaluation of viral URI symptoms and right-sided facial droop. On evaluation, she was found to have a right-sided hemiparesis. Fever, cough, and runny nose initially started 1/23/18, the day after immunization occurred. URI symptoms slightly improved, and then around 1/28/18, family noted right-sided facial droop and possible right-sided weakness (R arm > R leg). These symptoms stayed the same, but fevers and respiratory symptoms began again in the day or 2 prior to presentation in clinic on 2/2/18. Examination revealed right-sided hemiparesis and she was referred to the Emergency Department for evaluation by Neurology. MRI on 2/3/18 revealed a large left basal ganglia bleed.

1-2 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Nurse noted patient tolerated injection within normal limits. No adverse reaction noted by the nurse after the vaccinations were administered. At home and four hours after the vaccinations, patient’s mother noticed hives and a rash over both of patient’s legs. He began to run a temperature of 101.80 F and started to shake uncontrollably. Patient would scream when he tried to walk. The vaccination area appeared red and bruised. Mother stated that she then called the doctor’s office. The next day patient’s temperature raised to 103 F. He became lethargic and began vomiting. The rash had continued to spread to his arms and back. Mother took him to the hospital. He was admitted and released the next day. Mother reported that patient returned to health soon after he was released from the hospital. The hospital treated patient for dehydration. According to mother, the doctor does not want patient to receive this years 2nd flu vaccine. Patient receiving the next years flu vaccine has not been determined, according to mother.

1-2 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Seizure febrile, 2-3 days in hospital, fever very disoriented > signs, 930/1000 pm on 10/31/17 > time course. My daughter had her 15 month shots on 10/31/17 at around 930/1000 am and also a flu shot…. exactly 12 hrs later around 930/1000 pm at night she had a seizure and almost died in my arms!!!

1-2 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

On 01/29/18 patient came for well child exam. He had no fever or report of fever. He had conjunctivitis that day and was prescribed ophthalmic antibiotic drops. Closed Close to midnight the same day he had fever at home and had a tonic-clonic seizure. EMS called. Seizure lasted 20-25 minutes. Treated minutes, treated with medications, medications. Transported to ER. Head CT scan was normal. Patient was admitted for one day and discharged on only on DIASTAT in case of additional prolonged seizures. Initial temperature in the ER was 101.5. This was the highest temperature recorded.

1-2 years	1 day	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

Ataxia, acute flaccid paralysis requiring intubation, acute respiratory failure.

1-2 years	2 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Patient received vaccine Monday, October 16th, 2017 at 4 PM, and the following day patient had upper and lower extremity jerking and was unresponsive for 3min. She spontaneously regained consciousness but felt sleepy and slept for 20 to 25 min. Mother notice that patient had 102 F temperature and gave her ibuprofen oral. After six hours her fever was 102.5 and she another episode that lasted less than 5 minutes. She had a large wet diaper. She was irritable and cried for several minutes. She came to the ER where she was admitted.

1-2 years	2 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Status Epilepticus with generalized seizure without regaining consciousness for 1hr requiring intubation and generalized anesthetics with paralytics.

1-2 years	3 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Patient was brought to ED at Hospital by family member and was DOA. Patient was intubated and CPR was performed for 25 minutes until patient was pronounced dead at 16:18 on 10/5/17.

1-2 years	5 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

5 days after vaccination she had a fever. 7 days post vaccination she had a complex febrile seizure and developed ATAXIA, clumsiness, and weakness of left side. These symptoms are gradually improving.

 

1-2 years	5 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Thrombotic microangiopathy presenting as status epilepticus. Presumed atypical HUS with neg genetic tests. Treated plasma exchange, oral steroids and complement suppression.

1-2 years	6 days	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

“Hepatitis A vaccine Influenza vaccine Developed likely ADEM (acute disseminated meningoencephalitis) From Admission Note: Patient was in his usual state of health until the evening of 2/21 when he started with retching, abdominal pain, back arching, NBNB vomiting, diarrhea. Yesterday, 2/22, he continued to have a few episodes of NBNB emesis and diarrhea. The family called the PCP, who recommended supportive care at home. This morning at 7:30am (2/23) he woke up from sleep and was crying, had a small mucous vomit, then had a 15min seizure (bruxism and teeth chattering, eye deviation up and right, whole body shivering/shaking, minimally responsive). Otherwise he was recently well, fully vaccinated, no sick contacts, no fevers. No toxin exposures. Had vaccines a few weeks ago, had an elevated lead level of 9 planned to follow with the PCP. No recent traumas. He recently spent the last 5 months away from home and returned a few weeks ago. No FH of seizures or neurologic conditions. The family called EMS, per report the shaking seemed to have subsided by EMS arrival however patient was post-ictal. He was transported to hospital. There he had stable VS, irritable. He had a non-con CT that was reportedly normal. Labs with WBC 18, otherwise CBC normal, BMP normal, LFTs normal, no blood culture. Received 20cc/kg of NS. He was transferred to another hospital for ongoing care. In the ED, he was slightly post-ictal and not encephalopathy, responsive, apprehensive with caregivers, nonfocal neuro exam except for mild ataxia (vs peripheral IV in foot). He was tolerating PO. Abdominal US in ED was also negative. He also had a spot EEG which showed some possible L temporal slowing, non-epileptogenic. He was admitted to the floor for monitoring for unprovoked seizure. On the floor this afternoon, he has been slightly “”sleepy”” but interactive and arousable with a non-focal exam. Around 5:30pm today, he had a 15 min seizure (R eye deviation, unresponsive, intermittent whining sounds, bruxism, shaking, lip tremulousness). He had emesis with desat to 87% placed on the non-rebreather. Treated with 0.1mg/kg ativan with resolution of the seizures. Afterwards was post-ictal with some upper extremity posturing and overall rigidity and hypertonicity. He gradually recovered. By 6:30pm had R gaze preference but minimal residual rigidity. He had a full brain MRI which showed multiple areas of T2 hyperintense signal encephalitis/meningitis. He was admitted to PICU for monitoring and ongoing care, LP, acyclovir, antibiotics, and workup as per plan. His infectious studies including HSV PCR have been negative to date. He is receiving treatment with high dose IV steroids for presumed ADEM.”

3-5 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Ataxia of both legs and pain at injection site was the adverse event. He was admitted to hospital for 3 days until the ataxia symptoms improved. LP performed and meningitis panel done, blood and urine cultures done, CBC, CMP, Trileptal level.

3-5 years	1 day	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

Left thigh became swollen and painful from groin to mid-calf. Left knee became very swollen and painful – child unable to flex knee. Child became febrile about 36 hrs after vaccines given. Left knee was aspirated and child went to OR for knee irrigation. All joint fluid cultures were negative for bacteria, fungal CX pdg. Child had 48 hrs of IV ceftriaxone and clindamycin. Child seen 1/3/18 for F/U exam. She is improving but still has pain in Left knee and swelling of knee joint. She is able to walk with help of her parents or a walker.

3-5 years	1 day	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Patient began to experience joint pain, right ankle swelling, petechiae to both legs and feet 24 hrs after injection. She developed lumbar spinal swelling 2 days after injection. She was admitted to the hospital and diagnosed with HSP. There is no prescribed treatment and it will go away on its own. Drs cannot confirm if the flu shot caused this disease to occur.

3-5 years	1 day	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Per Hospital Discharge Summary: At 4 AM on 11/3/2017 patient vomited x1 then had a seizure like episode lasting approximately 45 minutes to 1 hour. Patient was taken by EMS to Medical Center and treated with 2 mg ATIVAN IV which stopped the seizure within a few minutes. Once stable, was transferred to another Hospital. Patient was diagnosed with febrile seizure with status epilepticus 2/2 MMRV vaccine. EEG and MRI were completed. EEG showed mild focal slowing in the left temporal region.

3-5 years	4 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

A few days after the vaccine, patient had a (non-febrile) tonic/clonic seizure, during which he became unresponsive/unconscious for 2-3 minutes, with twitching, and change in color (blueish). He was transported to the hospital via ambulance, during which he regained consciousness, and remained in a post-ictal state for about 30-40 minutes. The hospital did not perform any imaging or bloodwork, other than a blood sugar. Patient saw a neurologist later that week. Patient went on to develop daily seizure activity, and was diagnosed with Epilepsy, via EEG in January. At this time he is on 2 anti-convulsant medications to control his Grand mal seizures, and Myoclonic jerks.

3-5 years	7 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

Beginning about 1 week after vaccination and rapidly progressing, patient has decreased all meaningful social interaction. He now paces constantly, verbalizes imaginary play without interacting with toys, parents or peers. He was diagnosed with late onset Childhood disintegrative disorder on 1/23/18.

3-5 years	15-30 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

Atypical Steven’s Johnson Syndrome ~15 days post vaccination. Recurrence of SJS (as noted previously, ~3 months ago had SJS secondary to influenza B). Developed mouth + eye + penis involvement (ulcerations, clear discharge, pain, photosensitivity) starting 14 days post vaccination. Worsening over the next two days. History of preceding URI as well about 10 days prior to SJS symptom appearance. Patient admitted to the hospital on 5/25/2018 (15 days post vaccination) — started on acyclovir, IVFs, clindamycin (secondary to concern of bacterial superinfection of extensive mouth lesions), tobradex drops, and IV steroids (3 days; 1mg/kg/day of Solumedrol). Improving 4 days into hospitalization. Patient received ophtho consult, peds ID consult, and peds GI (to evaluate for esophageal involvement). Dermatology consulted via phone over the weekend. Etiology of recurrent SJS believed secondary to recent URI versus receipt of influenza vaccine — contacting VAERS for review and recommendation for receipt of influenza vaccine next year. At this time, tracking down lot/manufacturer of influenza vaccine received as well as DTaP.

6-17 years	0 days	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

Pt with anaphylactic reaction following administration of vaccine (FLULAVAL). Pt presented and was discharged home after fluids, BENADRYL, epinephrine, steroids, albuterol, and famotidine. Pt. was sent home on albuterol, BENADRYL, prednisone and was compliant with meds at home; however re-presented with systemic allergic reaction the following evening (10/11/17) and again required epinephrine, steroids, and famotidine and fluids. (BENADRYL and albuterol were given prior to arrival). Pt. improved but was however admitted for observation.

6-17 years	0 days	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

The patient received the vaccine in our clinic on 11/22/17 then on the drive home, he began having difficulty breathing and lethargy. He was taken to a fire station who bagged him then he was transported to Hospital where he was placed on CPAP because his blood gas returned with a PH 7.1 and an elevated PCO2 in the 90s. He received IVFs and antibiotics and was admitted to the PICU. He was eventually intubated/ventilated for 2 days. He was temporarily on IV epinephrine due to low blood pressure the day after the vaccine. He had acute kidney injury (creatinine doubled) 2 days after he received the vaccine and an elevated sodium to 166. This improved with free water. He continues to be hospitalized 7 days after vaccination due to electrolyte abnormalities but he at his baseline respiratory, cardiovascular, and mental status. The diagnoses in his hospital chart include sepsis and aspiration pneumonia but he was at his baseline health without signs of acute illness when he received the influenza vaccine.

6-17 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Child was hospitalized 10/11/17-10/14/17 for vomiting and dehydration due to Enterovirus. Upon discharge, child received influenza vaccine. She subsequently developed neurological sequelae and was re-admitted to hospital 10/15/17-10/18/17. CSF was negative for viral etiology, but MRI confirmed encephalitis.

6-17 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Approx. 10-20 mins after receiving the vaccine he was walking out of the office and passed out. He was taken by ambulance to hospital. He received an EKG that showed a conduction delay but nothing else. Since the vaccine he has experienced severe dizziness and shortness of breath apon standing and has been now diagnosed with a Dyautonomia Disorder POTS (Postural Orthostatic Tachycardia Syndrome). A support group of parents I am in there is a parent in that group that her son started to have all the same symptoms and has been diagnosed with the same disorder since his flu shot.

6-17 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

The night of the vaccine, patient began having terrible headaches. She has missed almost seven weeks of school. They vary in intensity but do not go away. To date, we have been to our pediatrician, the ER, a neurologist, and had an MRI. So far, no medicine has worked to stop the headaches.

6-17 years	1 day	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

“I am not sure if the vaccine was called “”FLUARIX,”” that may not be correct. The flu clinic said my daughter received a Glaxo Smith Kline quad prefilled syringe without preservatives, Lot # 27LY3. The day after the vaccine, she developed a rash with hives at the site of the injection, then a half hour to an hour later, she also developed facial flushing, felt hot all over, and her throat tightened (lump in throat, voice became hoarse voice higher pitched). She was treated with antihistamines, epi pen, and prednisone. First went to an urgent care clinic, then to the ER. Symptoms diminished after treatment.”

6-17 years	2 days	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

Pt received FLULAVAL on 10/28/2017. She developed fever and vomiting on 10/30/17 and presented to office on 10/31/17 with fever, tachycardia, hypotension, and rash. She was taken to ED and diagnosed with Toxic Shock Syndrome and admitted to the PICU for ABX, IVF, and dopamine. Over the next 24 hrs, she stabilized and was d/c on 11/4/17.

6-17 years	3 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

Patient received immunizations on 2/8/18. She presented to ED on 2/11/18 in respiratory distress/ septic shock and passed away the same day, presumably from Influenza B.

6-17 years	4 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

My daughter got her weekly allergy shot and then the flu shot. Four days later her hair started falling out in patches. She was diagnosed with an extreme case of alopecia areata. She had almost complete hair loss by the end of November.

6-17 years	9 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

“Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when “”your feet fall asleep,”” though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a “”cold”” sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.”

6-17 years	10-14 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Patient initially presented with a seizure after a soccer game, then proceeded to have 3 more seizures, followed by aphasia, difficulty using right hand. Initial MRI showed a 0.8 mm deep white matter lesion, likely demyelinating.

6-17 years	10-14 days	INFLUENZA (SEASONAL) (AFLURIA) (1121)

Complaints of general back and joint pain within 2 weeks of vaccination. Approximately 4 weeks after vaccination, complaints of severe tiredness, some weakness, and intermittent vomiting (on 24- to 61-hour periodicity). Approximately 5 weeks after vaccination, hospitalized with loss of coordination; inability to walk without assistance (falling); severe jaw, joint, and back pain. CT of head, chest X-ray, blood analyses, lumbar puncture, MRI of brain and spine; diagnosed with Guillain-Barre’ Syndrome. Immediately initiated plasmapheresis (5 treatments), followed by intravenous immunoglobulin treatment (5 treatments beginning after 3rd plasmapheresis treatment). Outcome pending; complete recovery not yet realized. GBS recovery expected to be prolonged; residual paralysis remains; permanent/permanence of damage unknown at this time.

18-29 years	0 days	INFLUENZA (SEASONAL) (NO BRAND NAME) (44)

34 weeks pregnant at time of vaccination. Start of preterm labor the evening after receiving the flu vaccination on 09/27/2017. I had just had my OBGYN appointment that morning and everything checked out fine. Received the flu vaccine at the end of the appointment. Went to hospital on 09/27/2017 for bleeding at 34 weeks gestation. Admitted for preterm labor. Preterm labor continued on and off for the next few days. Was in the hospital until 10/02/2017 and was sent home on bedrest. Preterm rupture of membranes occurred at home on 10/03/2017. Baby was born at 35 weeks gestation on weighing 5lbs 6oz. Baby kept in hospital for 12 more days. Due date was 11/05/2017.

18-29 years	0 days	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

“28 YO previously health active duty male presented to my aid station approximately 2-3 hours after receiving immunization with chief complaint of “”feeling puffy all over and being red.”” He denied chest pain or shortness of breath at that time. Upon exam he was remarkably edematous around his eyes, fingers and toes, with some extension proximally – his skin was erythematous in those areas, too. He was tachycardic to the low 110s and mildly hypertensive to 140s/90s. He denied any history of ingestion of new substances, drugs, insect bites, food allergies or drug allergies. I couldn’t technically call his reaction anaphylaxis because he didn’t have CP/SOB or evidence of hypotension, but I was worried about him progressing to that. I gave him 50 of IM BENADRYL, established a large bore PIV and gave him to liters of fluid, 50 mg oral hydroxyzine and 50 mg of oral prednisone and watched him in our aid station for 6 hours. His swelling improved remarkably, his tachycardia resolved and his blood pressure came down. He was monitored overnight by his battle buddies and appeared completely improved the next day in follow up with me.”

18-29 years	2 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

18 yo woman with a history of asthma was seen at ER for asthma exacerbation on 1/14/18 at 10 AM. She was treated with DUONEB and steroids with improvement of symptoms and was discharged on a course of prednisone. On 1/24/18 patient was seen for well visit with Dr. during which no complaints or abnormal exam findings were documented. A flu vaccine was administered at 3 pm. On 1/26/18 the patient was brought into hospital at 8:21 in cardiorespiratory arrest. After 60 minutes of resuscitation efforts, the patient was pronounced dead.

18-29 years	0 days	INFLUENZA (SEASONAL) (FLUAD) (1173)

I woke up Friday night around 11:00 pm with extreme pain left upper arm and body aches. Went to a stand-alone ER. The doctor told us it was just severe inflammation and gave me an anti-inflammatory injection, hydrocodone, and an Rx for TYLENOL 3. Over the next 36 hours or so I took the TYLENOL 3 around the clock and it didn’t seem to do much other than put me to sleep. I got worse over the course of time and by Sunday, 11/26/2017, around 2:45 pm, I went to a hospital ER with extreme pain to my left arm, swelling and redness covering the entirety of the upper left arm, high heart rate and blood pressure, extreme headache anytime I moved, body aches, severely dehydrated, and a fever of 102.7. A chest x-ray and blood test was ran. My WBC was at 29 and I was diagnosed with cellulitis of the left arm. I was admitted to the hospital, put on morphine, ibuprofen, and an IV antibiotic and fitted with a heart monitor. I was hesitantly released Tuesday evening, 11/28/2017 with an Rx of BACTRIM and Ibuprofen, told to watch my temperature and if I were to start running one, to contact my doctor immediately or come back to the ER. I still have the reddish/purple stain looking mark on my arm from the infection.

18-29 years	1 day	INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) (1166)

Had flu shot at 3 PM – worked till 7:30 PM. Went to a 2 hour dance class then home and to bed. At 3 AM – woke up with a headache and unable to move arms or legs. Admitted to hospital.

18-29 years	1 day	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Experience severe tachycardia with lethargy, weight loss, intractable nausea and vomiting. Spent a total of 10 day in the hospital. Admitted twice each time was a 5 day stay. Also, had 2 ER visits. Multiple tests were run. I ultimately ended up with an NG tube to supply nutrition as I was malnourished and lost 12 lbs resulting in me weighing only 102 lbs. I still have the NG tube and am on my 3rd month of sickness. I developed a positive ANA lab test and my IGE was elevated.

18-29 years	10-14 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

23 year old young lady, 20 weeks pregnant, who presented with symptoms 2 weeks after her flu vaccination. Symptoms include numbness/tingling on right from armpit down the right side of her body, ataxia, She gradually after that developed what she describes as block of blue discoloration in her central vision in left eye, decreased vision (20/200) in L eye first, which then also occurred in her R eye this occurred approximately within the past 3 weeks. MRI is showing patterns and distribution most concerning of MS with active demyelination. Based on Neurology consult, they feel it could be related to the flu vaccination she had on January 5.

18-29 years	Unknown	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

Patient received the flu vaccine on 10/18/2017. Two weeks later, patient reports coming down with a cold. She went to the Clinic (11/12) and then followed up with her PCP. She was referred to another physician as her symptoms were intensifying. Patient reports blurred vision, muscle weakness and feeling dizzy. She was admitted to the hospital (11/13) overnight patient reports that she has been diagnosed with Guillain Barre syndrome. Patient was told that the syndrome can last 4 to 6 weeks. After hospitalization, patient reports recovering at home.

30-39 years	0 days	INFLUENZA (SEASONAL) (NO BRAND NAME) (44)

Arm swelled within 1 hour to 4 times original size, by end of day could not walk, within 3 days paralyzed from neck down. After 2 weeks was administered a lower lumbar puncture and given 5 days worth of IVIG in 2 days because the paralysis was spreading to lungs and Neurologist stated I did not have 5 days to live.

30-39 years	0 days	INFLUENZA (SEASONAL) (AFLURIA) (1121)

I received the flu vaccine on Tuesday, 10/10 at 1:30pm. About three hours later, I started to have a debilitating headache. My headache never subsided. A week later, on 10/17, my headache progressively got worse, in my feet, hands and legs began to tingle and feel numb, and I was unable to void. I went to the emergency room on 10/18 and was admitted to the hospital on the neurology floor. I underwent a CT, MRI, and MRA of the head and an MRA of the spine. I also received an X-ray, EKG, and lumbar puncture. They put in a Foley catheter and received 1300 CCs of urine. A battery of blood tests were run with no conclusive results. I was placed on high dose SOLU-MEDROL of a gram a day for six days. They still do not know what the cause was, but have diagnosed me with transverse myelitis. I was discharged after five nights once I was able to void and have a bowl movement on my own. I still continue to have tingling in my feet/legs as well as headaches. I’ve been prescribed 9 weeks of prednisone and to follow up with a neurologist who specializes in myelitis.

30-39 years	3 days	INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) (1177)

Bell’s palsy started Monday morning at 710. Right sided facial weakness, inability to close right eye, right sided facial drooping.

30-39 years	3 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Fetal Demise 3 days after receiving seasonal influenza vaccine at 10 weeks pregnant.

30-39 years	9 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

I had an exacerbation of my myasthenia gravis about 1 week later. This is the second consecutive year in a row that I received the influenza vaccine and had a myasthenia exacerbation about 1-2 weeks later.

40-49 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

3 hours after administration of the influenza vaccine, experienced onset of right hand numbness and sensation and weakness. Traveled to right arm. Over next 36 hours had numbness and sensitivity spread to upper chest, upper back, across entire chin (left ear to right ear), down left arm and left hand. Had decrease in spatial awareness but no impairment. Problems with finger grasping thin objects such as a piece of paper. Admitted to hospital S/P abnormal brain CT. Brain MRI revealed hyperintensity lesions. Further assessment in progress to assess for demyelination. Waiting for neurology appt. 11/30.

40-49 years	0 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Within hour of receiving Flu shot noticed remarkable ringing in left ear that never have experienced. The ringing became worse followed by pain & pressure and partial hearing loss within two to three hours. Additionally, dizzy spells (vertigo followed). After pain and ringing in left ear didn’t stop consulted an Ear doctor (Otolaryngologist). Several test were done including MRI and Audiology test that determined suffered partial hearing loss. Given low dose of Prednisone which did not work. As of 5/1/18 I have continuous ringing in left ear and occasional strong pain and pulsating in ear. I never had any ringing in ear prior to vaccination and had FLU shot every year for 25 years with no symptoms. I am 100% that the Flu shot caused my condition. I am now sensitive to noise especially high pitch noises.

40-49 years	1 day	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Patient claims he was hospitalized several days after receiving the immunizations with sepsis and pneumonia.

40-49 years	1 day	INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) (1175)

Patient is a 44 y.o. male who was in his usual state of health. 3 weeks ago he received flu vaccine. For the days after the flu vaccine his feet felt cold. This resolved. His feet and legs began feeling numb. His hands began feeling numb about a week after the flu vaccine. Wife reports he had some flu-like symptoms, patient states he did not. He does admit to having some upper respiratory infections. One week ago the patient presented to the emergency room with left-sided facial drooping. He was diagnosed with Bell’s palsy. He was given prednisone and VALTREX without relief. He’s had tingling and numbness in his hands and legs since that time. Leg numbness has progressed and is worsening. He does not have leg weakness. His right leg went out from under him and he twisted his right ankle quite severely. He did not experience as much pain as he would’ve expected for that degree of injury. He’s had some sluggishness to his bowels but no other bladder or bowel symptoms. He has not had chest pain or heaviness but the tingling is coming up to his chest. He denies shortness of breath or difficulty getting a deep breath. High probability Guillain-BarrT syndrome given the symptoms. I spoke to neurology on the phone. Spinal tap was recommended. We’ll proceed with spinal tap and including IgG index. We’ll get MRI brain as demyelinating central process is also a possibility though less likely. Admitted to the hospital to evaluate for negative history for’s. Consider EMG. IMAGING: Xr Ankle 3 Or More Vw Right. Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM by MD. Xr Foot 3 Or More Vw Right Result Date: 12/11/2017 NO ACUTE OSSEOUS ABNORMALITY. Electronically signed on 12/11/2017 7:40 PM MD. MRI Brain Without Contrast Result Date: 12/12/2017 NO ACUTE INTRACRANIAL FINDINGS. MILD PARANASAL SINUS DISEASE. Electronically signed on 12/12/2017 3:18 PM by MD. Fl Lumbar Puncture W Opening Pressures And CSF Result Date: 12/12/2017 TECHNICALLY SUCCESSFUL LUMBAR PUNCTURE UNDER FLUOROSCOPIC GUIDANCE. FINAL PATHOLOGY RESULTS ARE PENDING. Electronically signed on 12/12/2017 4:32 PM by MD. HOSPITAL COURSE: This is a 44-year-old male that was admitted for ascending weakness with numbness and tingling in the perineal area and legs. He was found to have elevated protein on LP and was treated with IVIG. Patient did get 5 doses of IVIG. He is mostly independent but still requiring walker to ambulate. Still having some issues with bowel movements and is getting good bowel health for this. Patient will continue with his same medications prescribed as well as starting some SENEKOT at home to try to improve his bowel function I did get home health involved to check on them for a couple of days to ensure that he continues to get better make sure that his bowels continue to get better. He will also be referred to right physical therapy by his outpatient doctor once he feels safe to continue.

40-49 years	9 days	INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) (1175)

Severe and excruciating pain in left arm and shoulder weakness and nerve damage and pain in left arm. Diagnosed with Parsonage Turner’s Syndrome due to flu shot received on 9/27/17.

50-59 years	0 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

It has been almost six months since I had a flu shot at my place of work. I am unable to raise my left arm and any movement causes severe pain. I wake up at night when I move in bed and am not guarding my arm. The pain is excruciating. The nurse who administered my flu shot, injected me in highest point of my deltoid. I felt pain with the injection. I felt pain driving home and by early evening I was taking a pain reliever. The pain was so severe I could not sleep on my left side (the arm that was injected). This is incredibly painful, to the point of nausea. I also have poor range of motion and am unable to lift with that arm. It is a serious injury. To date, I have lingering shoulder pain, reduced range of motion, tingling of my entire body (especially during the night), numbness, muscle weakness and lack of coordination. At times I do have difficulty walking or balancing and I my vision has become worse. I believe this pain is permanent.

50-59 years	0 days	INFLUENZA (SEASONAL) (AFLURIA) (1121)

Pt in the evening on day of Immunization felt chills, aches, and run down and pain in his arm – so he went to walk in/ER and got LEVAQUIN, then next day couldn’t move, so he got doxy from another MD at hospital, then week later got AUGMENTIN and Prednisone – pt. had a swollen red hot sore arm around pneumonia shot – very painful – MD thought at 1st cellulitis, then Lyme disease, then pneumonia.

50-59 years	2 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

Within 36 hours, patient suffered frozen shoulder. Then debilitating moved to the wrist in the same arm, then spread throughout the body — hips, knees, ankles, belly. Deep, aching pain, not in the joint but near joints. Patient did not even consider the flu vaccine as a culprit until a supervisor inquired about the timing and location of the shot in relation to the onset of symptoms.

50-59 years	3 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

12/7/2017 received immunization. 12/10/2017 noted right arm immunization site extremely sore and developed severe headache, nausea, vomiting, stiff neck, pain radiating down into right shoulder and arm especially with head movement. 12/13/2017 developed diplopia with worsening of all symptoms. Around 12/23 experiencing global weakness, mental status changes, confusion, difficulties of concentration, speech and balance. Completely incapacitated by 12/25 when he presented to the emergency department. CT of brain completed with evidence of acute right cortical vein thrombosis. Transferred emergently to another Hospital. He underwent intensive workup confirming right posterior, parietal and frontal cortical vein thrombosis with associated subarachnoid and subdural inflammation with effusions. Left complete sixth cranial nerve palsy. Evidence of right cervical neuralgia. Hospitalized 12/25-12/31/2017. Symptoms slowly improving except for a sixth nerve palsy which is unchanged.

50-59 years	5 days	INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) (1162)

Onset of Bell’s Palsy following flu vaccination. Received Sanofi Pasteur FLUZONE QuadPFS2017-18 QUAD PFS2017-18 vaccine on 10/30/17. Initial onset of paralysis symptoms 11/4/17. Medicated via prednisone and valacyclovir following ER visit after symptoms worsened 11/6/17.

65+ years	0 days	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

On 10/3/17 I received the flu shot while on duty. I immediately developed a hematoma at the injection site. One and half hours later I started experiencing vertigo and nausea. By the time I got home around 4:00 PM I had to lie down due to my symptoms getting worse. I had difficulty keeping my balance when ever I was working. Getting up one flight of stairs I had SOB. I ended up going to bed early without dinner as my nausea was worsening. The next day symptoms continued. I had to fly on 10/5/17 and while there all my symptoms remained. I had vertigo, nausea, loss of balance. I had to limit my activities 10/5/ to 10/10. I also starting noticing I was having trouble hearing conversations. Upon my return my symptoms were slowly improving. I attended a dinner function on 10/11/17 and realized I was having trouble hearing conversation from my R ear. When I awoke yesterday 10/12/17 and I lost all my earing in my R ear. I managed to get myself into Dr office for a 9:45 AM apt. He assessed me and then I had a audio test down which confirmed a servere loss of hearing in my R ear. Dr. started me on Predisone 60mg x 10 days and then a taper plus zofran. I then went to Employee Health Center and reported this work injury and was also assessed by a NP. I absolutely believe the flu shot caused my loss of hearing and all my other symptoms. I have never had any of this kind of thing prior to the this flu shot. I don’t believe it is a coincident. My prognosis is the following. 33% chance full recover, 33% chance some improvement without full recovery and 33% chance this is permanent. Today my vertigo and nausea are improving slowly and I have lost my hearing in my R ear. Needless to say I will never take this vaccine again and I have had many in the past with no issues. I have selected disability or permanent damage but I don’t know the outcome of my treatment and I don’t see a choice that address this. It is a disability right now pending result of treatment which I am on day 2.

65+ years	0 days	INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) (1145)

Patient felt terrible pain in arm after shot on 9/22/17. After going home she had chills and could not get warm. Patient’s son reported inability to understand patient on phone. Went to hospital on Friday evening 9/22 and was admitted to ICU. Temp 104 degrees F, BP 82/66. Diagnosed acute kidney failure. Released 9/25/17.

65+ years	1 day	INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) (1145)

“Friday- complained of leg cramps and the sensation of “”not being able to move””; Saturday- tired, complained of pain in legs, “”feet were tingly”” and “”calves were tight””; Monday- worked, but Dr could not see until Tuesday afternoon; Tuesday- collapsed in bathroom, crawled to wall and pulled self up, went home from work at noon; Wednesday- MRI no new symptoms; Thursday- complained of arms tingling; “”legs were like noodles”” and “”couldn’t stand””; Friday- no strength in arms or legs, had trouble breathing, called ambulance at 1:09 pm; died at 2 pm.”

65+ years	1 day	INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) (1161)

Pt woke up the following morning with a drooping eyelid, like that associated with Bells Palsy. Because the patient has no current health conditions he does not currently see any physician. He felt the condition would improve and after almost 2 months he came back to the pharmacy for advice. I advised the patient that he needs to seek the advice of a medical doctor and I would report to see if there could be any correlation to the vaccine he received.