chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning her 3 year old daughter who on 18 Sep-2007, was vaccinated with her second dose of RECOMBIVAX HB generic.  Concomitant vaccines included DTaP (unspecified) administered into an alternative site.  On 18-SEP-2007, within several hours of receiving the hepatitis B vaccine, a small, fluid filled nodule developed at the injection site.  The patient's physician office was notified via phone.  No treatment was reported.  The patient was recovering.  "There were no laboratory or diagnostic tests performed."  A product quality complaint was not reported.  No further information was available.  Additional information is not expected.
SYMPTOMS BEGAN 1/29/21, FEVER 102, CHILLS, JOINT PAINS, RED RASH TO LEFT DELTOID AREA TO LEFT ELBOW WITH HARD SWELLING TO INJECTION SITE PER PATIENT.  PT CALLED HER PRIMARY PROVIDER. NOT SEEN IN PER BY PROVIDER. PT HAVE BEEN TAKING TYLENOL  /    SPOKE WITH PT ON 2/2/21 , SHE INDICATED THAT SHE IS DOING MUCH BETTER. RASH, SWELLING AND  FEVER RESOLVED.
Mom reports rash, Sunday 11am 8/29/10 angioedema torso/ext with pruritis.
Pt went to hospital 3/25/21 and 4/1/21 - had CVA (old with residual)
Shortness of breath; dizzy; my balance ain't great anymore when I walk; so I haven't been able to drive for two days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), BALANCE DISORDER (my balance ain't great anymore when I walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (so I haven't been able to drive for two days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), BALANCE DISORDER (my balance ain't great anymore when I walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (so I haven't been able to drive for two days). At the time of the report, DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), BALANCE DISORDER (my balance ain't great anymore when I walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (so I haven't been able to drive for two days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L033343, expiry date: 13-SEP-2017; lot # L040458, expiry date: 04-FEB-2018; lot # L048236, expiry date: 31-MAR-2018; lot # L045117, expiry date: 06-OCT-2018; lot # L027733, expiry date: 13-SEP-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Chile received the booster dose of DTAP and 1st dose of Hep A shot on 05/29/2003.  After about 5:00pm, child to weak, pale almost about to faint with clammy skin.  She was cradycardia, still and drowsy.  We administered O2 via nasal cannal and gradually became able to get up.
Pain and swelling in right foot and ankle, eventually moved into hips, back, and shoulders.  Unable to sit for long periods of time.  Flare ups are completely disabling.
Localized induration 3"x2", warm to touch, erythematous, patient reports itching.
Severe headache lasting 36 hours beginning 11:00 pm 3/19 through 2:00 pm 3/21. Approximately 1:00 am 3/20 entire body went through severe shaking that was uncontrollable. Lasted  more than 20 minutes before subsiding.
-Anxiety, shortness of breath, increased heart rate, tingling of hands, fingers and feet - icepack applied to neck. Paramedics evaluated, patient's husband took home to relax
08/08/2022 I came down with a COVID-19 positive test. 2 weeks prior I started to notice that I was having issues catching my breath. I then went on vacation with my family and then got extremely sick with a fever and I just couldn't catch my breath. I thought originally it was a sinus issue and it went on for about a week. I then tested positive for COVID-19 and I was feeling much better at that point. I was given recommendations for quarantining and afterwards I felt much better. As of now I just came down with a general cold and I don't think it is related to COVID-19 or the vaccine at all.
Patient experienced onset of prolonged duration of PVC's lasting weeks in length causing patient to contact primary care physician . PVC's were verified via physical exam and EKG.  Patient started on metoprolol 25 mg daily which  eliminated PVC's temporarily. Approximately one week later once again the patient experienced sudden onset of prolonged PVC's with sweating, lightheadedness which caused patient to access emergency care.  Emergency once again confrmed multiple  prolonged PVC's via EKG and physical exam.  Metoprolol increased to 50 mg daily which has so far kept PVC's under control.
Information regarding Flumist was received from a male consumer, a physician, who received a dose on an unspecified date. The pt's physician, reported that he developed a rash, lower lip edema, and itchy watery eyes and lacrimation increased. No additional info was available at the time of this report.
Several hours after vaccine administered, had severe dizziness (unable to stand), tinnitus/ringing in ears, sweating, and difficulty breathing for a short duration (30 seconds?). Vaccine was a Tdap.
Red, pimple-like dots all over body; "at least 150 on back alone". Mom says sent to urgent care.
PATIENT STATED THAT THE AREA OF THE INJECTION WAS VERY SWOLLEN AND HOT TO THE TOUCH THE DAY AFTER THE VACCINATION. THE AREA REMAINED SWOLLEN FOR ABOUT THREE DAYS AND AFTER THE SWELLING WENT DOWN, A HUGE BLACK AND BLUE BRUISE FORMED ON HER ARM ABOUT THE SIZE OF A BASEBALL.
Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of VARIVAX (Merck) dose and route unknown (lot number unspecified) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnant before getting the vaccine. Initial exposure to VARIVAX (Merck) was at unknown week of gestation. The patient's last menstrual period (LMP) and estimated delivery date (EDD) were unspecified). The patient was exposed to VARIVAX (Merck) during unspecified trimester. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from a registered nurse via telephone call.  The nurse stated that she vaguely remembers reporting the event, but she has no additional information to report at this time. Nurse stated she cannot remember patient's name and she believes she reported this event on behalf of someone else. No further information is available at this time. Additional information is not expected.
2wk post vax pt devel optic neuritis & exacerbation of preexisting MS
Employee received the Pfizer vaccine for the initial dose which was 12/17/2020 and received Moderna for the second dose on 1/5/202. Employee has had no side effects
TASTE OF MEDICINE AT THE BACK OF THROAT; BURNING SENSATION BACK OF THROAT; FEELING VERY FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was  pounds, and height was  inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced taste of medicine at the back of throat. On 27-JUN-2021, the subject experienced burning sensation back of throat. On 27-JUN-2021, the subject experienced feeling very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling very fatigue, and taste of medicine at the back of throat, and the outcome of burning sensation back of throat was not reported. This report was non-serious.
Started getting hives slowly on my neck and chest starting 1/1/22 with no known cause. Hives got worse throughout the week, and was unresponsive to over the counter allergy pills and cortizone creams. Hives spread all over body, including face, back, neck, chest, hands, thighs, and arms. I had a medical appointment via zoom on 1/4/22, and was told to go to emergency room due to my difficuly breathing. I continued to have difficulty breathing for the next week, and was prescriped epinephrine and prednisone (60mg/7 days) in ER. The hives were also unresponsive to the prednisone, which caused many other negative side effects (fatigue, headache, difficulty sleeping). MY primary care doctor extendned by prednisone prescription, but still failed to materially help. The hives took over 1 month to go away, several weeks after I stopped the Prednisone. I am continuting to take an over the counter allergy pill (Zyrtec and claritin).
Grandma called a wk p/pt recvd immun said 1 day following immun, pt lying in floor & said couldn't see at all; x 1hr, then vision returned; began to run high fever for about 3 days; c/o legs & feet, ankles & calves hurting, very  sick;
Former 33 week premie with RDS. Maternal HELLP syndrome, gest DM. Baby was breech, delivered by c-section. Mechanical ventilation for 5 days. Also received survanta. Was D/C at 3 weeks of age.  He received HIB/DPT(as tetramune),OPV,MMR on 01-04-2000. Developed significant muscle and fatty atrophy initially. Saw Orthopedics initially. Area of deformation now resolved. Howver child has been diagnosed with Autism Spectrum Disorder and ADD.Unclear if prenatal and antenatal history are likely more causative or the severe reaction to shots.  05/01/2007 MR received from PCP dated from Jan 4, 2000 to May 10, 2005. Pt. developed R leg muscle atrophy/wasting of the thigh first noted 5/2000. March 2002 pt. had Speech and Language Eval due to concerns that much of  child's language is not understandable.  Severe Communication Deficit, Reduced auditory attention skills and ? auditory processing skills. Reduced articulation skills. Developmental eval. 4/19/2002:  Mixed Language Disorder.  Macrocephaly.  Behavior Issues. Left OM.  R/O static encephalopathy.  Psych eval 11/03/2003: Attention problems, Autisitic Traits, Mild defecits.  Developmental eval 5/10/2005: high functioning Autism, making progress. 1/4/10 Autism Spectum Disorder.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M018624, expiry date: 28-MAY-2017; lot # M007768, expiry date: 27-JUN-2017; lot # M006923, expiry date: 21-JUN-2017 (incorrect product storage). Medical assistant reported that the vaccine underwent temperature excursion at 63.5 F for 36 hours. The vaccine was exposed to a temperature of 50 F for 12 hours previously as well. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Local approximate 4" diameter indurated reaction which mom reports was twice that size 1 day ago.
Pt. was seated upright in the chair. Nurse administered one vaccine into each arm. Pt. was breathing normally, color drained from face and she fainted. Nurse and pt.'s mom lowered pt. to the floor lying her on her back with a pillow under her head and bending her knees. Her eyes were open the whole time, she came to within a couple minutes and was talking and responding to questions. Mom helped her to a seated position. Pt. stated that she felt ok and was helped to her feet by nurse and mom. Pt. ambulated out of the room without issues.
soreness of my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 11:40 (Lot number: EW0172) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01May2021 11:40, outcome "recovered" (2021), described as "soreness of my arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior vaccination: None  Follow-up attempts are completed. No further information is expected.
Patient reports bilateral erythema, pain, and swelling in legs for 1 week after COVID vaccination. No fever no chills.  No itchy.  Blood pressure is elevated.
Varivax given SQ LA. MD reports low grade fever and swelling to left arm with pain. 7 1/2 cm x 6cm are of redness/induration
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: 5 minutes after 1st covid vaccine, patient became lightheaded, pale and fainted. While unconcious, patient was shaking (not sure if it was a seizure or due to fainting) for about 1 minute. We called 911 and patient regained consiousness shortly after. She was confused and was weak. EMS arrived and took vitals but all vitals were within normal range. EMS thinks patient had a vaso-vagal response and cleared patient to leave. After 20 minutes, patient said she felt okay and left the building.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves adult patient (age and gender not reported), who was vaccinated with a dose of PENTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was also a case of actual medication error due to inappropriate reconstitution technique because the following vaccine was not reconstituted with the DTap/Polio before it was injected. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.
No initial pain after injection. Body aches, headache and muscle soreness around midnight. Woke up around 4-5a.m. to neck/head pain, tense muscles on head/neck and notable pains in the jugular region. Very sensitive skin and muscle aches at this time. getting up to grab ibuprofen caused initial worsening of head pains that quickly subsided as blood pressure issue(?) symptoms came on (blotchy vision, lightheadedness, notably diminished hearing). took around 20 minutes to realize head/neck pain seemed to be caused by stiffness from an unusual amount of intense teeth grinding in my sleep. Waited around an hour and a half while drinking plenty of water and taking a single dose of ibuprofen along with a second dose of clonazepam before feeling comfortable/safe enough to go back to sleep.
First night had chills, very slight nausea and low grade fever (99.3) the next two days.  On the morning of April 7th I woke up with a swollen lip.  Throughout the day the swelling continued on the left side of face, then on bottom of right foot and later on top of both feet.  Went to emergency room and was treated for hives.  Over the next five days, the hives kept moving around, the right side of face, and then to upper lip.  I followed up with my Primary Care Doctor, who did extensive allergy testing.  All came back negative.  I felt that it was a result of my body reacting to the vaccine.  In addition, I was feeling weak muscles and joints that kept moving around.
Vaccinated on 3/24/2021 -- On day 6 started to notice that the site itched and had a hard lump in it. Day 7 the itchy area was larger area. Day 8 (4/1/2021) the site is now red (1.5 inches x 3 inches) and warm to the touch.
This was the second dose. No immediate reactions after injection. Approximately 6 hours later, internal itching began throughout my entire body. I also had a slight tingling of the tongue and lips. Benadryl did not ease the itching or mouth tingling. The internal itching by the next day and increased doses of Benadryl still did not help. Intense itching by day 3 as well as fever of 99.5. Saw an online doc who prescribed Hydroxyzine for itching.  It is now day 9 after the second vaccine. Itching internally has worsened. Still have tongue and lip tingling as well. I saw another online doc to tell them symptoms have continued and have worsened a bit and that I have been 24 hours without the Hydroxyzine. The prescription ran out the day prior. Doctor prescribed more Hydroxyzine. This time around the Hydroxyzine does not seem to be as effective. While it helps a bit with me sleeping, the itching is still quite severe.  The severe internal itching has been going on for 9 days and has affected my quality of life.  The itching is nonstop and is happening in all parts of my body. No other antihistamine is effective and is able to be taken during the day except the Hydroxyzine which causes grogginess and has become less effective.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 31-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Mom called and said her son was "aching like an old man" after receiving the flu shot on 11-15-2005. She said "he won't hardly walk, his neck and ears hurt, and he's crying." Mom took him to the doctor. Dr drew  labs as noted below. Dr thought it was an immune system response. Tx with ibuprofen was done and child was okay after noon on Wednesday 11/16/05. Tx resolved itself.
A few hours following the vaccine administration patient was found febrile and encephalopathic. She was admitted to the ICU with hypernatremia due to presumed dehydration and Sepsis due to UTI. Patient remains in the ICU today. Hypernatremia improving with IVFs. Receiving antibiotics for UTI.
Couldn't reach appointment for the second dose on the 7May2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Couldn't reach appointment for the second dose on the 7May2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Couldn't reach appointment for the second dose on the 7May2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Couldn't reach appointment for the second dose on the 7May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.
Patient came in for vaccinations on 2/28/2018. Before administering vaccines I asked screening questions to ensure client did not have any contraindications to vaccine. She denied pregnancy and did not have any other contraindications. On 3/20/2018 patient spoke with another RN and informed her that she had just found out that she was pregnant. On 3/27/2018 I called and spoke with patient and she reported that she found out she was pregnant on the same day she talked to RN and that she did not know her due date yet but has a prenatal appt. scheduled for 3/30/2018. I told her I would follow up with her sometime after her appt. for more information.  On 4/25/2018 I called and spoke to patient and she informed me that she had lost the baby approximately 2 weeks ago. She reports that her estimated due date was going to be 11/30/2018 which would make her estimated conception date 3/9/2018. Client reports that this was her second pregnancy and she has not had any prior miscarriages. She reports that she was prepared to be pregnant but was not trying to get pregnant at time of vaccination, so the pregnancy was unexpected. She denies any questions or additional problems or concerns at this time. LSW, RN.
Information has been received from a physician concerning a male "between two and four months old" who was vaccinated with a first oral dose of Rotateq (human-bovine). Subsequently the patient developed bloody stool. Approximately one week later the bloody stool was resolved and went away. The physician stated that he believes that the bloody stool was not due to Rotateq (human-bovine). He believes that it was due to the early introduction of cereals and other food products including guacamole to the infant at such a young age. Medical attention was sought. There was no product quality complaint involved. The patient's bloody stool was considered to be an other important medical event. Additional information has been requested.
Pt did not have any symptoms, I gave the wrong pfizer vaccine. pt is 5 y/o and was given the 6 month to 4 year dose.
p/dose 2 felt dizzy & lightheaded; 10FEB95 f/u had 3rd dose w/o addtl events;
1 hour after vaccination my skin turned red and itchy, my whole body was itching ,then around 10 pm I start having severe headache I vomit 2 times ,then the chills and earache started ,had fever of 101F chills continued till 8 am next morning now my throat is sore and my ears hurts ..I never been sick like this in my  life  ,passed out 2 times ..now about 24 hours later I still have severe headache ,earaches and start coughing