chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash at the injection site and today it is 2 inches in diameter and itchy; rash at the injection site and today it is 2 inches in diameter and itchy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 13Mar2021 as dose 2, single for COVID-19 immunization. Patient historical vaccine included first dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization and experienced sore arm. The patient's medical history and concomitant medications were not reported. The patient received second dose of vaccine on Saturday and experienced rash at the injection site and today it is 2 inches in diameter and itchy on an unspecified date in Mar2021. The outcome of the events was unknown.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Adverse event is "covid arm" 7 days after 1st injection. Symptoms include large, swollen, red area at the injection site. Slightly itchy and raised.   Pregnancy status: 23 weeks gestation, due 11/25/21
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 21-DEC-2018, the patient was vaccinated with an improperly stored dose (temperature was below 32 Fahrenheit (29 Fahrenheit) for 1 hour 15 minutes) of ROTATEQ (dose, frequency and route were unknown) (lot# R015607; expiration date: 21-APR-2020) for prophylaxis. No adverse effects reported. There were no previous temperature excursions. A digital data logger was involved. This is one of the three reports from the same reporter.
This spontaneous report as received from a licensed practice nurse refers to unspecified patients. Due to an error in her temperature recording process, the nurse discovered that oral ROTATEQ (Lot #, dose and route not reported) was stored at -5C (or 23F) for an indefinite period of time. The nurse was aware that administration of these improperly stored doses of vaccine would need to be reported and evaluated for possible readministration. She did not have the specific patient information or period of time of misexposure at the time of administration at the time of this report. It was not known if the patient sought for medical attention. Action taken and patients' statuses were not known. This is one of several reported received from a same source. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Information has been received from a registered nurse concerning her 13 year old daughter who in approximately 1999, at 5 years of age, was vaccinated with varicella virus live (Oka/Merck). On 18-February-2007, the patient developed a mild case of chickenpox, with less than 50 lesions and a low grade fever. Unspecified medical attention was sought. the nurse reported that chickenpox was going around at the local school. There was no product quality  complaint. It was also noted that the patient's two sisters developed an adverse event after vaccination with varicella virus live (Oka/Merck) (WAES#0703USA00658 and WAES#0703USA06659). Additional information has been requested.
Severe rashes on the entire face and necks 10 days after my first dose of Pfizer shot. Starting have rashes on neck first and then face. Red, hot, and itchy. Have been used Loratadine and Claritin. Didn?t contact my doctor about this.
Nausea, stomach cramps, body aches, head ache, and pain in left arm.
Pt to ED 5/5 by EMS for lightheaded. Pt with mild labored breathing, chest symmetrical, A&Ox3, sepsis BPA firing, no S/S of acute distress noted. 5/6 Patient oxygen dropped to lows 80s while on 6L nasal cannula. Oxygen increased to 15L . Pt COVID+ 5/5, maintained on Zosyn and vancomycin, azithromycin, remdesivir. 5/9 pt A&ox2 but forgetfull, on 12L HF and BIPAP at HS, no distress noted. 5/10 Multiple episodes of bradycardia, denies pain, appears pale and fatigue, bipap remains. 5/12 shortness of breath, on bipap, no complaints. 5/13 Pt oriented, denies pain, 7L high flow continued tolerating well, VSS. 5/17 A/ox4, no distress. 5/19 Patient AOx4 on 4L nasal cannula. Pt discharged 5/21.
It?s been a week since my vaccine and I still have a headache, I?ve vomited multiple times, and my head feels dizzy.
Fever, NauseaVomiting, inj site pain, chills, fatigue, nausea x1 day Narrative:
PT had the first dose on the left DM, and the injection site got swollen unusually and became blue. PT is a little underweight, but PT has a multiple health conditions that concern about the second dose. Soon after the injection, she felt dizziness. About 2-4 minutes after, PT stated she was having  tremor on her right arm and left leg, and the tremor was visual. She has been sitting for 15 minutes upon the pharmacist's monitoring and feeling fine.  Called PT PCP, Dr office and talked to Triage nurse. They will reach out to her and go over my report with the PT and will discuss the second dose.
BUD WAS ON 4/28/2022 AND PATIENT WAS VACCINATED 1 DAY PAST BUD ON 4/29/2022. PFIZER WAS CONTACTED AND REFERRED, VACCINE HAS A WINDOW MARGIN OF 48HRS PAST BUD, THEREFORE REVACCINATION WAS NOT NECESSARY.  COVID VACCINE PROGRAM REQUESTED VARS REPORTING
Information has been received from a registered nurse concerning a 21 year old female with no relevant medical history or pre-existing allergies,  birthdefects, or medical conditions who on     04-JAN-2007 was vaccinated with a first dose of Gardasil. On 22-May-2007, the patient was vaccinated Intramuscularly with a 0.5 mL second dose of Gardasil. Concomitant therapy included YASMIN, RITALIN and BENTYL. The nurse reported that the patient's mother called the office stating that the patient gained weight after receiving dose 2 of Gardasil. The patient did not have weight gain with dose one. The patient received dose two of Gardasil on 22-MAY-2007 and was a size two. The patient did not exhibit any illneses at the time of the vaccination. The patient then went to college and returned as a size 6. The only weight measurements that the office had were that the patient weighed 115 lbs in August 2005 and weighed 122 lbs when she received dose one on 04-JAN-2007. The present weight of the patient was unknown The patient sought unspecified medical attention. At the time of this report, the patient's weight gain persisted. Additional information has been requested.
Round 1/4 inch blister at injection site; Sore left arm; Redness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: fm9992) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number: 03, Manufacturer: Unknown;), for Covid-19 immunization; Covid-19 vaccine (Dose number: 02, Manufacturer: Unknown;), for Covid-19 immunization; Covid-19 vaccine (Dose number: 01, Manufacturer: Unknown;), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 25Aug2022, outcome "not recovered", described as "Redness at injection site"; VACCINATION SITE VESICLES (non-serious) with onset 25Aug2022, outcome "not recovered", described as "Round 1/4 inch blister at injection site"; PAIN IN EXTREMITY (non-serious) with onset 25Aug2022, outcome "not recovered", described as "Sore left arm". Therapeutic measures were not taken as a result of vaccination site vesicles, pain in extremity, vaccination site erythema.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was reported as 29Aug2022. Events happened 3 1/2 months after shot. Dose received: More than 3. No Known allergies.
Patient reports injection site became red and swollen the day after 2nd dose of HPV vaccine given, and remained swollen and painful for several days. Patient states the injection site left a "dark spot" on her arm with both the 1st and 2nd doses of the vaccine, but much worse with the 2nd.  None visibly seen by nurse today.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient within 10 minutes of second dose broke out in hives over arms and trunk of body. gave benadryl 50 mg. monitored for additional half hour. patient no issues with breathing or itchiness. relative picked up patient to bring home.
72 hours after second dose of Pfizer vaccine: Pt developed intermittent diarrhea which persisted and worsened into a colitis-like condition (mucous, cramps).  Pt started taking probiotic (Visbiome) and symptoms gradually subsided over the course of 4 months.
After immunization, patient stayed near pharmacy as advised as she was nervous about the shot. After a few minutes, she stated she felt dizzy. She laid down as she stated she feels better that way when she usually gets dizzy. She rested for a little, she drank some water, and EMT arrived to check her blood pressure. She sat up, and said she felt much better after EMT cleared her to leave. She stayed sitting for another 5-10 minutes before leaving and stating that she is fine. Total time course was approximately 20 minutes.
About 3 days after the vaccine 2nd dose, I noticed I was getting  pleurisy chest pains. This time, the pain was on the left side (when normally is on the right side). I went to the doctor and was prescribed colchicine 0.6mg and prednisone 10mg. I am still having chest pains which has not resolved.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. No adverse effects reported
I had blood clots in both of my lungs, they were several tests but I don't know what they are. They have removed the blood clots with surgery. I am still recovering, I am due for a test in june for a check up. I also do have another clot in the back of my knee, which I am still needing surgery for.
I received the Moderna Vaccine, and I started to have a rash around the injection site 7 days post first dose. At this start of the rash it was sore and itchy. My Rash seemed to get worse on day 10-11 post first shot and became more wide spread on arm and hot to touch.
she received the first dose of her Pfizer-Biontech Covid19 vaccine 25Feb2021.  Then, 8 days later on 05Mar2021 she received a dose of the Moderna Covid19 vaccine; got really sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Feb2021 as dose 1, single and second dose of Moderna Covid19 covid-19 vaccine m-RNA (MODERNA COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 05Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she "got really sick" on an unspecified date in 2021. She wants to know if she's covered or if she should get the second dose of her Pfizer series? The response to the patient's question was that the different covid vaccine products on the market have not been compared to each other nor has switching between products been evaluated. Provided CDC recommendations from the interval do that state that if a dose was given at a shorter interval than the 4 days early, that dose should not be repeated. The outcome of the event sickness at the time of reporting was unknown.  Follow-up attempts are completed. No further information is expected.
"Covid arm" - delayed cutaneous hypersensitivity Large red circle patch, about 8" in diameter, itchy and hot to the touch. It lasted six days before it was completely gone. I used tylenol, aloe vera gel, hydrocortisone cream, and ice packs to ease symptoms.
arm swollen, red, itchy, . Spreading around to underside of arm.  Face " feels funny" though no visible swelling or redness noted
Patient first described feeling light headed within a couple minutes of vaccination. We had him sit down and he then began reporting nausea and dizziness as well. His blood pressure and pulse were fine, no SOB noted. Gave him orange juice and cake doughnut in case of low blood sugar issues. Took small amount of each. Pt and wife left to go to ER after about 30 minutes with no resolution in SX.
Arm very sore and hard. Temp went as high as 104. Delirious, nauseas, painful. Friend was using ice to cool her off. Arm swelled up and was red. Still sore as of 7/11/14. Thinks she is breaking cut in shingles now. Has developed a rash and spots. Lasted 2-3 days (the temp did).
Ten days after receiving my second dose of the Moderna vaccine, I noticed a cluster of red bumps on  my leg. Over the next few days those bumps started to blister and I was in horrible pain, so I went to Urgent Care, where they diagnosed it as Shingles. I'm in my 30's and hadn't been overly stressed, so I was told by the healthcare provider to mention the Shingles in case it came about because of the vaccine. Since I had just received the vaccine, the timing seemed suspicious. I was put on an antiviral medication. It's been 12 days after I first noticed the bumps and I seem to be healing up. I finished my antiviral medication yesterday.
Day 1: Itching began about 30-40 minutes after injection. Welts began appearing 2 hours later on arms, legs, and back. Took Benadryl 36.5 mg every 4 hours.  Day 2: Woke up with hives all over body, including face , started Prednisone 10 mg x3 tablets and continued benadryl 25mg every 3-4 hours.
has an intermittent knee issue, it pops up every so often / Knee started on Saturday before the 2nd dose / last night very painful could hardly walk; knee swell; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (Batch/Lot number: unknown) 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: JOINT INJURY (non-serious), outcome "unknown", described as "has an intermittent knee issue, it pops up every so often / Knee started on Saturday before the 2nd dose / last night very painful could hardly walk"; JOINT SWELLING (non-serious), outcome "unknown", described as "knee swell"; PAIN (non-serious), outcome "unknown", described as "Pain". Additional information: Caller states, the patient got his first Pfizer vaccine on 14Feb2021, second one the other day 07Mar2021. He was done, no side effects, did very well, very happy with Pfizer. He had an intermittent knee issue, it pops up every so often, and he went to orthopedic doctor, they drain and give a cortisone shot, he's been out of work for two days, the Knee started on Saturday before the 2nd dose, by Sunday, it was really big, Made appt. on Monday to see the Doctor, he was able to drain the fluid and not able to give the cortisone, and he told him that because you have to wait 2 weeks after Pfizer vaccine before you can get a steroid. On Sunday, or Saturday, the knee was starting to swell and the patient knew it was going to get worse.  By Sunday night, the knee was really swollen and the patient could hardly walk, and the caller means that. The caller thinks the patient has to wait 2 weeks after the Covid shot before he can take a steroid, the caller thinks that's the rule. The only thing the orthopedic doctor could do was drain the patient's knee and took out a lot of fluid and couldn't give the cortisone because the patient just had the covid two days ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10 minutes after injection she complained of swollen tongue.   She asked for bendadryl and had her own Epi-pen 0.3.  emergency was called.   She was given 50mg benadryl and 0.3mg epinephrine which seemed to help.  A few minutes later the paramedics arrived and took over.  She was conscious when taken by ambulance.
Family report that pt received booster Pfizer vaccine on 1/11/22 and then family brought pt to ED at medical center   on 1/14/22 with change in LOC, significantly increased confusion, delirium, somnolence, loss of appetite.
Mom called office reporting child having an allergic reaction. 12 hrs later after receiving vaccine child complained of joint and body aches, fever, chills, TYLENOL was given and helped.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 05-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified). which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 328 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Mild swelling, tenderness at injection site;  day 2 post-injection - mild dyspnea on exertion, cough, rhinorrhea, no fever;  day 3 post-injection - fatigue, muscle aches, dyspnea on exertion worsened affecting activities of daily living, cough + rhinorrhea worse but no meds taken, left upper quadrant abdominal pain with mild tenderness, difficulty sleeping due to cough, pulse ox SPO2 85 - 90 during dyspneic episodes but 90 - 95 remainder of time, no fever day 4 post-injection - mild dyspnea on exertion at beginning of day, cough improved - mild and non-productive, rhinorrhea improved
Two days after the shot was given arm swelled and large red area from shoulder to elbow. Followed by days of a headache. Weekend On call doctor was paged. Instructed to give TYLENOL and BENADRYL. Followed up with administering pediatrician regarding my concern over the shot given at age 10 well visit versus the CDC recommended age of 11-12. I am awaiting a follow up email regarding the medical center protocol.
tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 doses of advil,vomiting
12 x 8cm erythematous,indurated warm,tender area @ shot site starting >24hrs p/vax;but <48hrs;
Patient reported adverse event when she was due for her second dose. Pressure on chest, trouble breathing, drop in blood pressure, dizziness. Started in the evening of her vaccine and she reports it did resolve on its own a few hours later.
tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the second of two reports.  A patient of unspecified age and gender received their first dose of  BNT162B2 (lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516038 same drug and event in a different patient
Chief Complaint: Patient presents with: Fussy child - pt was seen this morning and got her vaccines has been crying since then. Congestion. Gas.     History of present illness:   Seen today, immunized, 1hr after event (shots) began to screen to the point she could not hold up head. Screen was notably high pitched. (1:30 onset of screaming; given Tylenol) now falling to sleep, baby wakes and screams.  Refuses bottle.  Assessment and Plan   Pain in legs after immunizations Discomfort relieved by defecation No sign of neurologic sequelae after DTaP   PLAN: Cold packs to legs. Tylenol as directed earlier today. Dip nipple in Nature Ease (sucrose,) prn   Discussion:     Follow up instructions given and questions answered.  I have outlined  indications for prompt  return  for re-evaluation, and have encouraged a call if parents themselves have concerns which I have not addressed or anticipated.    Return advised:  Call prn
DAY AFTER VAX, LOCAL ITCHING.6 DAYS AFTER VAX,ITCHING GEN,TONGUE SWELL,PERIO. EDEMA,RHINORRHEA.
Jan.  13, 2022  Admitted to hospital with excruciating pain in chest.  Diagnosis was a blood clot in heart.  No prior history.  Began blood thinners immediately.  The doctors do not believe it came from the legs.
p/vax pt exp GBS;Annual follow-up dated 11/27/00 provided no additional data.
After the first shot I had swelling in my arm for 2 days and I had shivering for about 20 minutes. I also developed stiffness in my posterior pelvic area and the doctor said it could be Cauda equina syndrome because of golf. It happened about 3 or 5 days afterwards. It would come back every 2 weeks for about a day. It was not painful but when I play golf I cannot completely turn. I seem to have weakness in my legs near my groin area. If I walk up stairs there is pain there. It was not tender. I had no rotational point of my upper body to turn when I play golf. I could not complete my swing. I could not rotate my hips. I have heard about other people having the same pain. I have had injuries before but it is unrelated to this type of pain it is different. This happened a few times after the second dose also. I had the second dose on 04/22/2021 (EW0176) and 24 hours after my deltoid part of my shoulder swelled like 3 times its size. I could not raise my arm over my head. That lasted for 4-5 days. It was sore and tender. On the 4th day I started having migraines and headaches. I have never had a migraine headache in my life. I had one the 4 and 5 day after the vaccine and one 10 days after. It is very incapacitating. I had sensitivity to light, sound, and walking. I took aspirin and used heat compresses. It was mostly a frontal migraine. My oxygen levels sometimes would get to 93 and 94. I have had prostate cancer before, and after the second dose I started having trouble passing urine. I talked to a urologist and he said it is possible that I might have prostate cancer again and it had to be cauterized after because I could not pass urine. We are working on that and I will have some tests done later.
Arm of injection site sore for an unusal amount of time. Painful to lift arm, radiates to elbow and neck, difficult to sleep.