chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports within 10 minutes of being vaccinated feeling "warm" in the left hand and tingling. Acetaminophen P.O. is administered by medical order, since we could not not solve the symptoms she is transferred to nearby medical facility.
Patient reported flu-like symptoms the day after the vaccine - headache, lightheaded, and nausea. Also said had injection site reaction of redness, swollen, and hot to the touch. Rash still present as of 1/10/19 when patient reported event, but stated that it had decreased in size and swelling had also decreased. Patient did not have to make a doctor's visit as of 1/10/19 when adverse reaction was reported, but did have to stay home from work for 2 days because she felt so bad.
Redness and mild edema and induration left arm in area of vaccination. No fever, no systemic symptoms.
For 2 days after the injection, the area around the injection was tender, but there was no swelling or other side effects.  On Sunday 3/28/21 around 4:00 pm, a 2" x 1-1/2" area around the injection site turned light red, became sore, slightly swollen, and warm to the touch.  Temperature is 97.2 degrees.  Applied over-the-counter Hydrocortizone cream last night and again this morning.  Did not make it better or worse.  Will apply Benadryl next.
very muscle hurt; skin felt like it was on fire; had difficulty moving; fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 18th March 2020, refer case ID: US2020AMR135486).   On 6th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced fever, muscle pain, burning sensation skin and movement disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and movement disorder were recovered/resolved and the outcome of the muscle pain and burning sensation skin were unknown.   It was unknown if the reporter considered the fever, muscle pain, burning sensation skin and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient experienced 4 days difficulty in moving, very muscle hurt, fever for 24 hours, skin felt like it was on fire. The patient's body temperature was reported as 101-101.5 Degree F. The case has been linked with the cases US2020AMR135104 and US2020AMR135291 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135104:Same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR135486:same reporter
Reddened, raised area on left upper arm. Pt reported she had chills, low grade temp (1 degree), soreness.
Developed itching of scalp 2 hours post injection, spread to arms the next day.  3 days later developed hives over her wrist and knees.  On day 4 hives worsened, and experienced brief (~1hr) period of chest heaviness that self resolved.  Treated with Zyrtec which helped itch for a day.  Benadryl not helpful.  Day 5 woke with morbilliform rash over trunk and fever to 101.9, lasted a few hours, all symptoms resolved over the course of day 5.
Information has been received from a physician concerning a 10 year old male with no pertinent medical history or drug allergies who on 13-AUG-2007 were vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot# 658021/0827U). There was no concomitant medication. On 15-AUG-2007 the patient developed injection site redness and swelling. Medical attention was sought through the reporting physician. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. This is one of three reports from the same source.  Additional information has been requested.
This spontaneous report has been received from a pharmacist and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that from 27-FEB-2017 to 24-APR-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # N003993, expiration date 20-OCT-2018; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature range from 47 degrees Fahrenheit (F) to 77 degrees F for a total time frame of 15 minutes. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014153:
Rash on left arm in a large oval around injection area.  Beginning to dissipate but another rash in lower part of same area began to appear 2/17/21
About 2 hours after receiving vaccine patient became listless, developed swelling of face and feet; threw up once; had fever 101.3. Swelling resolved. Fever was treated with Tylenol or Motrin. She remained sleepy but was doing much better by next day.
***************COVID BREAKTHROUGH CASE************ On May 15, we had a small gathering with people that are in our little bubble. This included my husband and our kids and a few friends. On Sunday, my daughter took a test before coming to my house for a birthday party for my husband and she was negative. On the very next day May 16, she then tested positive. That same day me and my husband both felt ill scratchy throat we thought it may be allergies. On the 18 me and my husband took test and they both came back positive. I sent a message through the portal telling my Dr I tested, and they prescribed it. Molnutiravir was the medication given it was 4 200mg tablets. I was feeling better it this May 27 I woke up feeling stuffy and the inside of my ears hurt, and I have a headache.
Information has been received from a physician concerning a 17 year old female with asthma, hypersensitivity (NOS) and menstrual cramps who on 08-AUG-2006, 19-Oct-2006 and 07-Apr-2007, was vaccinated with first (lot# unspecified), second (lot#653938/0954F) and third (lot#657005/0314U) doses, respectively, of GARDASIL vaccine. Concomitant therapy maybe included LOESTRIN, albuterol and ANAPROX. It was reported by patient's mother that since the third dose the patient sleeps too much, is tired and is "foggy." Unspecified medical attention was sought by calling office. At the time of this report the patient had not recovered. Additional information has been requested.
Fever of 101, severe headache, body aches and fatigue. After about 15 minutes after the shot was given she had numbness and tingeling in both arms for about 10 minutes.
Child became autistic. 60 day follow-up dated 9/22/00 provided no additional data.
Heavy menstrual bleeding for over 2 weeks. Still hasn't stopped. Headaches often.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 30-SEP-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster.  The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Tingling in throat, heart pounding and racing, dizziness, flushed skin, sweating, feeling hot
Left lateral arm with expanding redness. 6 cm diameter mild warmth to the touch. No pain or itching. No fever. Minimal firmness. Treatment = Recommended ice application to site three times per day for 5 days. Continue ZYRTEC.
12/11/2001-client received vaccine at school. Very tense within ten minutes. Started to leave the room, looked back and then fainted. Revised, leg elevated for five minutes. then client was assisted to a chair. School LPN took client to cafe. Where he told her he had not eaten that morning. Client return to (his home)room when the RN felt that he was alright. Mother didn't feed him. 12/12/2001-client was at school without complaints.
scattered thoughts; I had a severe headache; felt terrible all day; I now have neurological symptoms; My symptoms are dizziness; Vertigo; Balance problems; Brain fog; Trouble concentrating; trouble thinking straight; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Oct2021 10:30 (Lot Number: Ff8841) at the age of 46-years-old as single dose for covid-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. No other relevant medical history and concurrent conditions. Patient received concomitant medications within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 18Sep2021 01:00 PM (Lot Number: Fe3592) at the age of 46-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had a severe headache and felt terrible all day. He had neurological symptoms since he had had the second vaccine. Patient symptoms are dizziness/vertigo, balance problems, brain fog, trouble concentrating, scattered thoughts, trouble thinking straight. The date of start of reaction/event: 09Oct2021 at 10:30. No treatment received for the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.
post herpetic neuralgia; herpes zoster; Information has been received from a lawyer and a patient of unknown gender (currently about 81 year old) regarding a case in litigation on 12-OCT-2020. On or about 12-JUL-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, route, lot# and expiration date note reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
on 4/6/2021 around 5pm pt got a headache on the left side mainly, felt like throwing up and stomach ache.
On day 12 after receiving the second dose of the vaccine, developed hives/rash covering face, neck, trunk, arms, and legs; characterized by mild itching and redness. No pronounced throat tightness/swelling.  Being treated with oral Benadryl and topical Benadryl cream with no improvement in symptoms (now at day 13 post-vaccination).
Chills, myalgias, nausea, headache, lump in throat, pain at left arm injection site. Resting tachycardia, heart rate 122. Orthostatic hypotension, standing BP 62/42. Resolved with IV promethazine and normal saline 2 liters.
No adverse reaction, but an error: Pentacel and Pedvax Hib were given. Patient received two doses of HIB on same date.
Patients wife called for help and said he seemed to be asleep. Staff helped hold him up so he did not fall out of his walker. He did have a pulse and appeared to be breathing. We removed his mask to make sure airway was not blocked. He was not responsive to verbal or physical cues. 911 was called. Patient was laid on ground and had bp checked by emergency services. He did wake up but was taken to hospital.
Patient started to feel faint after vaccines. Patient did not actually pass out. Patient did not fall. Dr. was alerted and patient was monitored. Patient did not develop any other symptoms. Patient left with mom.
Got the Moderna Vaccune on left arm. Nothing happened after the ahot but 1 day before the week he got sick. We only assume itbis due to the vaccune of moderna for cocid but don't know if the sickness is due to the shot
canter sore on tongue; This is a spontaneous report from a contactable other HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 patient developed a canter sore on tongue on an unspecified date. Event outcome was unknown.  Information on the lot/batch number has been requested.
FEVER, BODY ACHES, CHILLS , FATIGUE, LEFT UNDERARM IS SWOLLEN, PAINFUL AND TENDER
Patient had very high blood pressure(214/112) the day following the flu shot, difficulty breathing, hoarseness, very pale, very weak, dizzy, fast heart rate.   Saw family doctor on 10-29-2008 doctor prescribed Atenolol and patient was told to go home and rest for a couple of days.  Patient was unable to work the rest of the week.
Patient started feeling tingling in the left arm (opposite of arm where injection given). Was scratching upper arm but lower arm started to get red. Took BP and pulse 5 min post immunization it was 135/95 mmHg. Gave 50 mg of Benadryl and checked BP again 10 minutes post after given. It was 140-92, coming down but still elevated, patient wanted the paramedics to come. At 25 minutes post injection, BP and pulse were 130/86 and 94 BPM respectively.  EMT arrived 2 minutes after last BP check, same BP when they checked. After discussion between paramedics and patient, the patient felt better and did not want to be taken. Called boyfriend and he is taking her to urgent care for monitoring as arm still tingles. Site of injection shows no irritation, redness or swelling.
Post first vax, no untoward effects. Post second vax, received on 01/11/2000, he experienced arthritis symptoms, pain in his shoulder, neck, and elbow with tingling and stiffness. He also had decreased range of motion due to pain in his left shoulder. The patient had left shoulder mild warmth on physical exam on 4/20/00. Treatment included Vioxx. The information received on 04/26/00 reported the symptoms as ongoing.
My daughter developed severe allergies and sensory processing problems. Of course I can't prove the vaccines she received according to the CDC schedule at the time (she had all her shots on time up to age 2) are what caused her issues but I suspect they are.
Information has been received from a registered nurse for the pregnancy registry of GARDASIL, concerning a female patient with abnormal period (end of March 2010 and beginning of April 2010) who on 01-DEC-2009 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number 661841/0653X, expiration date 25-FEB-2011) IM. On 27-APR-2010 the patient was vaccinated with a 0.5 ml second dose of GARDASIL (Lot number 665607/1332Y, expiration date 25-JUN-2012) IM. There was no concomitant medication. The nurse reported that the patient was given the second dose of GARDASIL and then had a pregnancy urine test that was positive on 06-MAY-2010. The nurse reported that the patient went to a clinic with complaints of pain with urination (onset date was 22-APR-2010) and intermittent left lower quadrant pain. A routine pregnancy urine test was done according to guidelines at the clinic (patient did not know her last menstrual period). The patient's exam was within normal limits. Laboratory tests performed included tests for sexually transmitted disease (STDs) with no results provided. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Pt presented to ER & claimed neurological damage following DT peds; no further info available;
Profound fatigue lasting 2 weeks, shortness of breath, pain in knee joint. Not completely recovered.
high fever to 104 w/sz x 10min;? h/o similar rxn w/vax in past no record of prior rxn in chart;seen in ER tx w/APAP;sx resolved;Ibuprofen given 30' a/event;
inj site red swollen, warm to touch, T102, poss d/t resp infect
Excruciating pain in hip and groin area. She was admitted twice to hospital from emergency room and on home health for 6 days in between.
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4404009-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Weight: (unspecified date) 124 lbs; (2022) 105 lbs, notes: tremendous weight loss from 124 pound to 105 pound and was only weighing 102 pound. The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events. ,Linked Report(s) : US-PFIZER INC-202101361686 Same patient/reporter/drug, different AE;
diarhea; loss of balance; disoriented; food allergy; nausea; feeling faint; low grade fever; stomach pain; tired/sleepy; Sleepiness; malaise; hives; Itchy; This case was reported by a consumer via call center representative and described the occurrence of food allergy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 3 days after receiving Shingrix, the patient experienced hives and pruritus. On 27th August 2019, the patient experienced food allergy, nausea, felt faint, low grade fever, stomach pain, tiredness, sleepiness and malaise. On 9th September 2019, the patient experienced diarrhea, loss of balance and disorientation. The patient was treated with benadryl (nos) (Benadryl), topical steroid nos (Steroid Cream) and eucerin (nos) (Eucerin Cream). On 6th September 2019, the outcome of the low grade fever was resolved with sequelae. On an unknown date, the outcome of the food allergy was unknown and the outcome of the nausea, felt faint, hives, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance and pruritus were recovering/resolving and the outcome of the disorientation was resolved with sequelae.   It was unknown if the reporter considered the food allergy, nausea, felt faint, hives, low grade fever, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance, disorientation and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed nausea, faintness, low grade fever, stomach pain, tired/sleepy, malaise. The patient developed itchy hives 3-4 days after her dose 1 and they are still ongoing and in a variety of locations. The patient went to the doctors regarding these symptoms on 9/6/19 and was diagnosed with food allergies, patient disagrees with this diagnosis. The patient was prescribed benadryl at bedtime, and a steroid cream for the hives. The patient stated that had diarrhea, loss of balance and disorientation. The patient did not consent to follow up.
On Saturday, September 4, 2021, at 3:00pm, I left work and went outside to my car. I noticed that everything seemed really bright. Almost whitewashed. Enough that I felt uncomfortable driving. Then about 10 minutes later,  I started feeling a tingling sensation on my right palm. The tingling crept up my fingers and into my finger tips. After a minute or so, my finger tips on my right hand went completely numb. Then I noticed the same tingling  feeling start on my lower lip and quickly, it too went numb. I called 911 knowing that something wasn't right. It was then that I lost all ability to say the words my brain was trying to say. Random words were coming out and then I starting forgetting worlds altogether. Easy things like what I had eaten for lunch or where I was parked was impossible for me to answer. I just couldn't remember the names. By the time the paramedics came to me, the tingling was gone and my brain to mouth connection was back but my memory was still really bad. That is when I started getting a headache. The headache lasts for about 4 hours or so.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions. On 11/5 all vaccines were administered within 3 hours   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received,  Secondary reporter Information was added; Sender's Comments: Non-serious case.
Severe headache, confused state and diagnosed with encephalitis. H - Aug 21 - Sept. 12, 2009. 12/04/09 Discharge Summary, ED, and hospital records received for DOS 08/22/09-09/09/09. Pt. c/o stomachache and headache x 1 day; not focusng at all; walking off balance. Admitted to ICU; tx. with IV fluids. Tamiflu and antibiotics; renal consult for elevated creatinine; ID and neurology consults obtained Intubated on 08/28/09 for airway protection. Focal seizure activity required treatment with Ativan and Fosphentoin. Continued to have confusion and combativeness; treated with antipsychotics, transferred to psychiatric facility.   DC DX: meningoencephalitis, cognitive disorder; acute renal failure, encephalopathy