chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUZONE QUADRIVALENT  twicely which is just 3 weeks apart  with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA311407(CLUSTER).  This case involves a 8 months old female patient who received influenza quadrival A-B vaccine [Fluzone Quadrivalent] twicely which is just 3 weeks apart with no reported adverse event.  The patient's past vaccination(s) included Fluzone Quadrivalent on 16-SEP-2023.  The patient's past medical history, medical treatment(s) and family history were not provided.  On 07-Oct-2023, the patient received a dose 2 of suspect Influenza Quadrival A-B Vaccine Suspension for injection lot UT8144LA expiry date: 30-jun-2024 via unknown route in unknown administration site for prophylactic vaccination (immunization) and fluzone quadrivalent  twicely which is just 3 weeks apart  with no reported adverse event (inappropriate schedule of product administration) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone quadrivalent  twicely which is just 3 weeks apart  with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
hives on neck, cheeks, behind ears and on scalp. itching on areas described before plus arms, legs, chest and back. Face also appeared reddeded and puffy. My scalp is somewhat raw from scratching in my sleep.  nausea when i got up in the morning.
Legs are very red and splotchy after her vaccines today  6/17/2020 @ 4:12 PM
Internal muscle became very swollen.  This grew in severity the whole day to a point of such extreme pain it could not be touched even lightly.  It became hot to the touch and all this spread up to the shoulder, around the back side of the arm and all down to the elbow.  Ice or Advil did nothing to touch it.  Could not sleep for 3 nights.  This took two additional  days to subside to a more normal sensation.  Currently, the severity of pain has diminished and it is no longer hot to the touch,  but this arm feels permanently damaged and at night I cannot lay on this side or move the arm after it is inactive without severe pain if on that side.  There is still tenderness on the back side of the arm, now at 8 days later.
We received from a health care professional via the agency following information on 29 OCT 2007: A 89-year-old man, born on 15 JUL 1918, was vaccinated with Fluvirin, batch-no. 78428, i.m. on 23 OCT 2007. The patient died shortly after the vaccination after he left the facility and walked down the hall. Caller felt that individual was properly screened, reported no allergies to any component, and filled out the waiver for the vaccine prior to administration, and had prior flu vaccinations. The reporter felt the death was coincidental based on the age and history of the patient. Company assessment: Seriousness criterion: death. Causality: insufficient data. Expectedness assessment according to manufacturer label: Death after Fluvirin is not expected. No change in benefit-risk-ratio. No measure necessary. Addendum We received from a health care professional via the medical agencies additional information on 29 OCT 2007: The batch-no. was 78478 (and not 78428 as previously reported). No change in assessment. NA07-005622
DEVELOPED DARK BROWN VAGINAL DISCHARGE THAT TURNED TO RED BLOOD ON 12/31/20. SHE IS AN EMPLOYEE AT THE NURSING HOME AND WAS ADVISED BY HER SUPERVISOR TO CONTACT HER PCP.
24 hr p/vax pt exp rxn inj site of 5cm cellulitis,severe erythema,warmth & tenderness. Exp nurse gave doses.Booster not given in last 10 yr.
I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown.   Information on the lot/batch number has been requested.
LOWER ABDOMINAL PAIN; BACK PAIN; BODY PAIN; RIGHT LEG PAIN; FEVER; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problems, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced body pain. On 11-APR-2021, the subject experienced right leg pain. On 11-APR-2021, the subject experienced fever. On 19-APR-2021, the subject experienced back pain. On 22-APR-2021, the subject experienced lower abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, right leg pain, and fever on 12-APR-2021, and had not recovered from back pain, and lower abdominal pain. This report was non-serious.
Started out at approximately 3:30 with severe chills , pain to injection sight and surrounding areas up into neck and under arm with swollen lymph node noted under left arm near injection site, noted fever of 102.4 took 2 Tylenol 500 mg to easy pain and fever at approximately 4pm fever continued through the day heart rate was elevated 119-130  blood glucose was elevated 250-350  O2sat was normal 99 bP was normal 106/68  temp . Continued with fever and chills, increased fatigue , until approximately 2am did take repeat dose of Tylenol at 10pm. Woke up on 10-7-21 with no fever but extremely tired and continued pain to injection site with swollen lymph node to left armpit still , if lymph nodes do not improve over the next few days  I will report to my physician office
Approx 930 am child rcvd shot them ambulated to holding area. Student fell to floor, twitching noted face down - was out for only 15-20 sec. Pale in color Log rolled onto back and was able to answer questions, name, date. Resps even and unlabored. USS - 121/8 86 Resp 24 SaO2 96% - O2 with non - rebreaths placed on child 935 EMS was activated - no bumps - noted to head mother notified - to come to hospital. (L) deltoids - no redness or swelling at vaccine site. Continued to monitor - elevated legs and child continued to answer questions, ate cereal for breakfast and mothers name. 940 EMS arrived - US - 108/67, 101, resp - 24, SaO2 100% on O2 temp 98 finger stick 101 - child sat up and able to ambulate to chair. 952 mom arrived - recommended by hospital staff for mom f/u with ER. but mom called her doctor who advised may take to clinic. Mom decided to take child to doctors office - 1005 - mom left with child via w/c to take to doctors office child alert and oriented x3. 1002 - health care provider - reported to health dept. 12/15/09 4:12pm call made by RN F/U call to childs home spoke to dad, very limited information given to nurse - stated patient is doing okay.
Approximately 20 minutes after receiving Moderna dose # 1, as patient was being observed for 30 minutes due to hx of pen allergy- patient began to experience facial numbness to right cheek area, crossing over mouth towards the left side of her face. Also noticed slight numbness of fingertips to right hand. Patient attributed this to her mask being on too tight and receiving the vaccine in right arm and was discharged from clinic without stating the above. As patient began to drive 50 minutes to home, she called her husband and stated she felt numb inside her right gum and cheek- he advised her to return to clinic. Patient presented to me as screener for COVID testing line- stating she was just here but didn't feel right- I escorted her inside- steady gait, no SOB, dyspnea, speaking in full sentences, upon reaching discharge area, VS 98.3- HR 61 reg- resps 18 unlabored, b/p 122/72 pulse ox r/a 100%. Pt asked to remove mask, no circumoral pallor or swelling noted, uvula midline, right cheek area is reddened, no rash or hives noted, pt described as "hot". MD  contacted via phone- spoke with patient, who agreed to stay for observation, no further intervention at this time. Drs also consulted- patient observed for 40 minutes, was discharged to follow up  with PMD - no resp distress, lungs clear upon auscultation by RN, repeat VS- 98.7 hr 59 reg- resps 18, b/p 116/73 O2 sat 98% r/a-
BODY ACHES, FEVER, COUGH, SCRATCHY THROAT, NASAL CONGESTION
I developed a high ringing in my ears about five days after getting the first dose of the vaccine. The ringing is intermittent, but noticeable and troubling at times. I've been to the internist to have my ears cleaned just in case it was caused by wax build up, but that didn't help. I have never had any issues with my hearing whatsoever.
COVID 19 positive on 10/25/22 shortly thereafter I started to developed ear and nasal congestion; facial pressure; persistent coughing when eating.
The history is notable for 92F well known to dept p/w generalized malaise, fatigue, weakness--received 2nd COVID vaccine day prior. Has been trying to eat/drink normally, but admits to me probably less than normal.  No focal weakness, pain, rash..  Exam is notable for On my eval after initial interventions by PA, pt is ambulatory, tolerating PO, well appearing, normal complexion, normal/stable VS..  Patient at risk for Vaccine reaction, dehydration, ACS, AKI.  Our plan is Workup unrevealing of acute pathology. Pt feeling well after tylenol and IVF, ambulating well. Discussed by phone with her son, agreeable to bringing her back home if she's up and moving about okay.  Understanding about her symptoms mos
Patient endorsed frontal headache, chin paresthesia, rash approximately 22 minutes after vaccination. The child was observed for approximately 1 hour and at discharge home found to have no worsening of rash, improved frontal headache and paresthesia complaint
seizures, grand mal w/in 12 hrs of vax; diffuse encephalopathy w/bilateral lower extremities & rt upper extremities paresis, aphasia;
Patient reports developed profuse diaphoresis, chills, and nausea at 0300. Upon waking up in the morning, patient reports significant localized inflammation around the site (described by patient as a welt) approximately 1.5" in diameter.
My second Moderna vaccine in May; Minor body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My second Moderna vaccine in May), MYALGIA (Minor body aches) and HEADACHE (headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My second Moderna vaccine in May), MYALGIA (Minor body aches) and HEADACHE (headache). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My second Moderna vaccine in May) had resolved and MYALGIA (Minor body aches) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-092400 (Patient Link).
pt recv vax 9NOV98;saw MD 17NOV98 for hepatitis;further testing including liver biopsy suggested autoimmune hepatitis;pred started 27NOV98 w/marked imporvement;
Red rash that started a couple inches below injection site appeared day 6 after vaccination. Rash grew fast for 24 hours until half of arm was covered, including injection site. Stopped growing after taking 5mg of zyrtec. 3 days post start of rash it is still there but getting lighter.
Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tremors Flu-like feeling Fatigue Heart arrhythmia, palpitations and chest pain Off balance occasionally
Undiluted Pfizer BioNtech vaccine was administered.  No acute reactions were observed during the 15 minutes wait period after vaccine adminstration.
Friday  2/12 2pm - Vaccine injection 6pm - soreness at site  9pm - noticed bright redness around site, soreness continued Saturday  2/13 8am - redness around the site has enlarged, soreness continues 8pm - redness around site continues, now very hard to the touch  and raised like a welt Sunday 2/14 9am - still hard to touch and raised like a welt, also itchy 9pm - still hard to touch and raised like a welt, area of redness may have decreased slightly, also itchy Monday 2/15 9am - redness decreased some, soreness decreased some, still raised and hard to the touch, still itchy
Patient's mother called and said her daughter felt nauseous and vomitted 20 minutes after the injection was given.  While at daycare patient vomitted again at 12:00pm.  No other sign or symptoms reported.
Raynaud's phenomena to fingers of both hands  - also fever, chills, body aches  self limited ( I hope)- went away after 48 hour hours  - kept hands warm
Having an allergic reaction; Itching; It has been slight on the back; It is down around my buttock, around my hip; Having an allergic reaction; Itching; It has been slight on the back; It is down around my buttock, around my hip; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: EN6203) via unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Stated, he was having a, he got the Pfizer shot on Wednesday and he was having an allergic reaction, he guess but he was not sure, he was itching on an unspecified date in 2021. Treatment in response to event, stated, as No, because it has been slight on the back and this morning, it was down around his buttock, around his hip. Stated that patient was on unspecified other medications. Stated that patient got the second shot on 18Feb2021. The outcome of the events was unknown.
Seizure (febrile?) - went to Emergency Room on 6/26/10. Fever of 101 degrees diarrhea x 1 on 6/25/10.
Tingling in feet and legs, muscle spasms, severe headache, neck and shoulder tension, heart palpitations, fainting and now tinnitus
Information has been received from a physician concerning a approximately 19 year old female patient who "1 month ago", on approximately 04 JAN-2010 was vaccinated with GARDASIL (lot number not reported). "One month" after vaccination, on approximately 04-FEB-2010 the patient experienced a swollen sore right arm. Unspecified medical attention was sought. The outcome of the patient was not reported. No further information is available.
SEIZURE SYMPTOMS SOON AFTER. About 15 mins after I had early signs of focal aware seizure (aura) - pins and needles in the face, hands, feet, and very warm face.   (RASH AND ITCHING  AROUND INJECTION SITE NEXT DAY  AND ONGOING.  )  Slowly, twitching started sporadically lasting 1 - 3 seconds with 5 - 10 minutes in between. Length of twitching stayed the same but slowly became more often. I knew something was going to happen, so I did not want to go home not knowing if it would become more severe or when it would become severe.  As time wore on,  twitching and body movement increased especially in left thigh where a stronger seizure usually starts. In time,  it became almost constant with arm, shoulder and leg movement and then increased to sporadic whole body movement. Took Klonopin. Took about 15 - 20 minutes to take effect I was attended to by doctor and EMS.
Rash on face. Progressed to swelling of face by 12/22. Benadryl given at home. Prescription for prednisone given in clinic on 12/23.
I had the expected body aches , pains , fatigue and chills approximately 24 hours after the shot. I controlled them with Tylenol and they were gone in 24 hours but? I have had at least one to 2 times per week since the shot the same symptoms of body aches, pain , fatigue and chills come on and affect me for approximately 24 hours each time. This has gone on for the past 4 weeks. They feel exactly like the very first set of body aches, fatigue  and chills I had 24 hours after the shot.  They just keep hitting me out of the blue . I will be feeling good and I suddenly start feeling sick again. I have not been able to find anything that says that continuing to have these side effects for 4 weeks coming and going is an expected side effect and I am starting g to get very concerned and scared to take the 2nd shot.
transient cerebral ischemia; herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 01-DEC-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered abdominal pain and mid back pain along with a painful burning rash. Pt was diagnosed with herpes zoster. Pt also suffered numbness in her bilateral arms associated with lightheadedness and feelings of near syncope. Pt was hospitalized and diagnosed with ransient cerebral ischemia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and transient cerebral ischemia was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the events herpes zoster and transient cerebral ischemia to be disability.  Upon internal review, the event transient cerebral ischemia was determined to be medically significant.
Vial  was thawed on 1/11/21  and due to expire on 1/16/21 - patient was immunized with this expired vaccine on 1/22/21.
Patient received first dose of Pfizer LOT FA7484 (Exp 10/21) into left deltoid at 11:15 AM on 7/30/21.  Immediately following vaccine, patient was advised to stay at pharmacy for 15-30 minutes to monitor for delayed reactions.  At this point, patient passed out in chair and was lowered to the ground and became responsive after a just a few seconds of incident.  Pharmacist on duty immediately called 911 and EMT evaluated patient for safety.
RN administered 0.2ml intradermal and should have admin. 0.1ml intradermal.
got them a month after vaccinated/ suspected vaccination failure; got them; had ugly rash; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient friend. The age at vaccination was not reported. The patient received Shingles vaccine and got them a month after vaccinated also had ugly rash two weeks are vaccinated. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and  laboratory confirmation for shingles were unknown.
I am a diabetic patient and I take insulin (short acting and long acting) and metformin (1000 mg) daily to control my blood glucose. I am noticing from past few weeks (~3 weeks) my glucose reading are abnormally high (~350- ~390) even after taking my regular insulin after lunch or dinner. I haven't changed anything in my diet and I am doing my regular exercise. The only thing that has changed is the vaccination.
Itching started on the back of my head and neck 10 days after booster. Hives slowly progressed to the rest of my body, most commonly showing up on my chest and abdomen. A friend had the same reaction 10 days after her booster and had success with relief by taking Zyrtec + Pepcid during the day and Benadryl at night. Her doctor also gave her oral steroids which I prefer not to take, so I decided to try the OTC route. I take Zyrtec+Pepcid every other day and half a Benadryl each night before bed (and have done this since the end of December). I have tried weaning myself off of this regimen but if I skip a day (like I did yesterday) the hives come back worse than ever. I have been documenting this process through photos and would be happy to share, if helpful. I am a creature of habit and have not used any new lotions, shampoos, laundry detergents etc. and I eat the same sorts of food each day. The only thing that has changed recently is the booster, so I believe it is the cause of this reaction.