chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to her daughter who was a female patient between 9 months to 1 year old (currently 7 year old). The reporter said that her daughter had an allergic reaction that included a rash, trouble breathing, and diarrhea to ROTATEQ when she was between the ages of 9-months and 1-year. On an unknown date the patient was vaccinated with the first dose of ROTATEQ (lot # not reported) (strength, dose, route unknown). On an unknown date (reported as between the ages of 9-months and 1-year) the patient experienced a mild allergic reaction after the first dose of ROTATEQ. On an unknown date (reported as between the ages of 9-months and 1-year) the patient experienced a more intense reaction to the second dose of ROTATEQ resulting in the child being rushed to Urgent Care. The outcome of the mild allergic reaction and a more intense allergic reaction was unknown. The causality of the events and ROTATEQ was unknown. Additional information has been requested.
delayed reaction by 7 days. Rash over arms and in between fingers. applied cortisone cream 2% however still itchy. outcome promising not effecting airway of breathing in anyway. Advise can use Benadryl if needed. Advised may cause drowsiness.
Sore arm; Felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and SOMNOLENCE (Felt sleepy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and SOMNOLENCE (Felt sleepy). At the time of the report, PAIN IN EXTREMITY (Sore arm) and SOMNOLENCE (Felt sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Vaccine given 2/6/17 at approximately 0800. Irritation began that evening with itching. The next day red, swollen and itchy. When scratched - burning. No relief with hydrocortisone. Today it has gotten bigger.
First noticed severe warm red rash with hives all over body @ 6:30 am on 2/8/2014 lasted until 11:30 AM 2/9/2014. Went to the ER and Benadryl was prescribed.
Tuesday July 19,2022. 13:30 I was originally suppose to give patient a Twinrix (HepA-HepB). I was also going to give patient a MMR and a Varivax. I had pulled the Twinrix from the fridge and in my head I thought I had also pulled an MMR and a Varivax. I accidently had pulled out another Hep A and a Hep B. I had administered the Twinrix on the right deltoid and the Hep A and Hep B I did both on the left deltoid. I did not realize that I had given two of the same shots until I had spoke to patient about other vaccines. I did let patient  know that I accidently had given them the wrong vaccine. Patient had asked me if everything was going to be ok and I had spoken to someone before I gave her more information. He had told me everything was going to be ok. I let patient know that everything was going to be ok and we had talked about her coming in a week for the other vaccines that were missed (MMR and Varivax.)
Mom states child was shaking and wobbly for about 5 minutes no LOC, vomited once afterwards, cranky, whiny today, otherwise tolerating oral fluids well.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with no pertinent medical history and no known drug allergies who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # unknown), IM 0.5 mL, and on 11-MAR-2009 was vaccinated with the second dose of GARDASIL (Lot # 659655/0940X) 0.5 mL, intramuscular administration. It was reported that the patient was pregnant and was administered GARDASIL. The patient was given PLAN B which was not effective. LMP was 12-FEB-2009 and EDD was 19-NOV-2009. Laboratory test performed on an unspecified date included PAP smear, GC/Chlamydia and beta hCG. No adverse effect was reported. The patient sought unspecified medical attention. Follow-up information was received from a registered nurse, via telephone call, indicating that the patient was planning to terminate the pregnancy. The nurse reported that the reason for terminating the pregnancy was that the patient and her husband "were not ready for a family". Upon internal review, "Termination of pregnancy" was considered to be an other important medical. Additional information has been requested.
Mild to sever headache; Sinus infection like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in right arm on 10Mar2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On 11Mar2021, patient had experienced mild to severe headache and sinus infection like symptoms. It was unknown if therapeutic measures were taken for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache and sinus infection was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
L deltoid area swollen, red, warm to touch and painful. 5.5 x 6 cm Started on 2/9/10, redness & pain disappeared 2/15/10.
Description: 47 y/o female AD SM reports the onset of undocumented fever chills commencing 3 days after BIOTHRAX. SM went on to develop cough chest soreness, and other oral difficulties including painful swallowing and difficulty opening her mouth. She needed evaluations by ENT and her PCP. The member was concerned her symptoms could be related to her receipt of BIOTHRAX. Flu-like symptoms> 96 hours Start: 12/03/2007 Comment: Flu-like symptoms started some 3 days after AVA #6. The symptoms persisted beyond 5 December 07. Chest pain Start: 12/05/2007 Comment: The chest discomfort was described more as a 'soreness'. The chest soreness was accompanied by a cough. Odynophagia (burning pain w/swallowing) Start: 12/18/2007. SM also noted difficulty opening the mouth. She was referred by her PCP to ENT for an emergency CAT scan.
intermittent swollen gland since vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (intermittent swollen gland since vaccination) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (intermittent swollen gland since vaccination). At the time of the report, LYMPHADENOPATHY (intermittent swollen gland since vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
I felt achy and lethargic the next day (Thursday) and also had a sensation in my mouth on the right side of my tongue. The achy/lethargic feeling was gone by Friday but the sensation in my mouth is still there 5 days later. Feels almost like a slight burning/tingling feeling. Hard to describe. The sensation in my mouth has not gotten worse over the 5 days but has persisted.
Patient was administered a vaccine that expired on 10/12/2022 on 12/1/2022
PATIENT TESTED POSITIVE FOR COVID19 ON 11/21/2021 AT INDIAN PATH COMMUNITY HOSPITAL. TRANSFERRED TO HOLSTON VALLEY MEDICAL CENTER. STATED HAD BEEN FEELING BAD FOR OVER A WEEK WITH INCREASING COUGH, SHORTNESS OF BREATH. ON 10L NC IN ED, VERY WEAK, FEBRILE, UNDERGOING CHEMO FOR LYMPHOMA. PER MD NOTES, ACUTE HYPOXEMIC RESPIRATORY FAILURE SECOND TO COVID19. ADMITTED TO STEP DOWN UNIT. CONTINUED STEROIDS. STARTED REMDESIVIR. OVERNIGHT O2 REQUIRMENTS INCREASED, PLACED ON BIPAP. INTUBATED 11/23/2021. BILATERAL PNEUMONIA, SEPTIC SHOCK, HYPOTENSION REQUIRING PRESSOR SUPPORT. STABILIZED, EXTUBATED 11/26/2021. DISCHARGED 12/2/2021 TO ENCOMPASS REHAB FACILITY. PATIENT DIED AT HOME 12/24/2021.
Day after shot, red lump somewhat achy at injection site.   Disappeared after several days.   Day 8 large red itchy spot size of tennis ball appeared at injection site.  Used benadryl creme for itch.  Spot began to fade after about a week.  Can still slightly see outline but no longer itchy.
Patient came into pharmacy ten days after receiving vaccination. She said she was experiencing a significant amount of pain in her arm, starting the day after receiving the flu shot. Patient said she can hardly lift her arm or turn her steering wheel and that the pain is now radiating up her neck.  We strongly suggested she contact her doctor to discuss these symptoms and be evaluated.  She called her doctor from the pharmacy and doctor suggested she go to the ER.
tested positive on a PCR; tested positive on a PCR; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 at 19:30 as dose 1, single (Lot number: FH8028) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "unknown" and all described as "tested positive on a PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected
hives appeared on rt arm p/taking capsule #2;pt took #3 & #4 1hr p/taking an antihistamine as ordered by allergist;the hives left after vaccine was completed;no further complaint noted per phone call 13JUL98;
died from the vaccine; This is a spontaneous report from a non-contactable consumer from a Pfizer sponsored program. An unspecified age and gender patient received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medication history included and concomitant medication were not reported. On an unspecified date, the patient was died from the vaccine. Caller was a consumer who was interested in receiving the FDA-approved BNT162B2 vaccine and is asking where can she get it. Caller said that in their area, the BNT162B2-labeled vaccine is not available. In addition to that, caller said that her employer wants them to be vaccinated. Caller also expressed her feeling of being uncomfortable in receiving "experimental vaccine" since she does not know what are the side effects and she also mentioned that someone in her family died from the vaccine after the first dose in which that someone never woke up again from sleep and was previously healthy and no medical issues. Caller said that since it is approved already, it should be available and not mislead people in getting the experimental vaccine. Caller said the line kept "breaking up" and could not hear properly. Autopsy was not reported. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died from the vaccine.
This spontaneous report as received from medical assistant refers multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapy were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # N001348, expiration date 31-OCT-2019) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 1.9 degrees Celsius (°C) for 30 minutes. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009392:
High fever (4 degrees elevated), chills, muscle aches, fatigue, head ache
Fever, significantly more pain/redness at inj site, more numbness/pain in fingertips of RIGHT hand.
About 35 minutes after injection had swelling of tongue and face, tingling lips and pressure felling just above collar bone on throat. I took benadryl as soon as I felt tongue swelling , but it did not stop the advancement of more swelling in my tongue. Eventually I got throbbing jaw pain from the pressure of my tongue.
Patient's first dose of COVID-19 vaccine was Moderna. Second dose was Pfizer.
I contracted covid and had two positive tests even though I was fully vaccinated.  I felt exhausted, slight shortness of breath, runny nose, slight headache and then loss of taste and smell around the 3rd day.  I still do not completely have my sense of taste and smell back and it has been over a month since I first contracted Covid.
MILD BODY ACHES; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported. On an unspecified date, the subject experienced mild body aches, and slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild body aches, and slight headache. This report was non-serious.
Migraine-type headache, lethargy, sore arm around injection site,  behavioral irritability.  All symptoms began about 18 hours after injection and lasted approximately 24 hours. No professional Treatment sought and PCP was not consulted as symptoms subsided. Patient pursued Bed rest and minimal activity.
Pt. face swollen and complained of pain and pressure behind her eyes and rear of her head.
The 1st shot I had terrible arm pain, this time I took 2 Aleve and didn't have all that pain. What I had the 1st time was a ringing/buzzing in my ears/head. I again have the same thing this time.; This is a spontaneous report from a contactable healthcare professional who is also the patient.  A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL3249), intramuscularly, on 11Jan2021 at 06:45 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history includes status as pre-diabetic. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL1284) on 21Dec2020 at 04:45 in the left arm. The patient is allergic to epinephrine, norethindrone and Comtrex. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication was reported as "none." Prior to the vaccination the patient had not received any other vaccination within the last four weeks.  On an unspecified date after the second vaccination, the patient experienced ringing/buzzing in her ears/head. She explained that after the first shot she had ringing/buzzing in her ears/head (AER 2020508246) and she again has the same thing this time. She commented that it never really went away before having this second shot. She also said that she only really hears the buzzing when things are quiet.  As treatment for the event ringing and buzzing in the head, the patient's primary care physician told her to take "Ginkgo" which she says helps somewhat. The clinical outcomes of the ringing/buzzing in the ear was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
This is a spontaneous report from a contactable consumer. A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EP7534), via an intramuscularly in the left arm, on 22Apr2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten intolerant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EP7534), intramuscularly in the left arm, on 01Apr2021 at 14:00 (at the age of 23-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced appendicitis on 25Apr2021 at 04:00, which required hospitalization for one day from an unspecified date to an unspecified date. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 25Apr2021. Therapeutic measures were taken as a result of the appendicitis, which included an appendectomy. The clinical outcome of appendicitis was recovered in Apr2021.
Pt given Pneumovax 23 first, as I was giving her the Fluzone HD in right arm pt stated she was feeling warm and appeared flush. Gave 1st IMZ at approx 2:30, and reaction started about 2:33-2:35. I stayed in the room with the pt and talked with her, she claimed no problem breathing or any adverse reaction in her left arm. Flushing was in face and neck, as this cleared pt complained of sharp stabbing pains in lower back area. We gave pt a Benadryl at 2:37, and called paramedics at 2:40 as pt was still in pain. Paramedics arrived 2:43 and pt said she was feeling better (pain level went from 10 to 5) and refused to go to hospital. She stayed in pharmacy area for next 5-10 min stating she was not in pain and wanted to go home. Pt called us at 3:42pm and stated she was home and better.
On Friday, July 16,2021, Patient  was wrongly administered 0.5ml of Pfizer Vaccine instead of 0.3ml by a Volunteer Nurse vaccinator.  Incident was reported to Management,  Patients will be notified by medical staff.
Swelling in entire left upper arm from shoulder down to elbow, area was red and painful) Fever, dizzy, weak, headache, whole body aches (in all muscles).
Exactly 24 hours from the vaccination time patient stated that she had a raised reddened area around the injection site(left deltoid)and she started experiencing what she called "flu-like" symptoms. Approximately 32 hours after vaccination she stated that her temperature reached 101 degrees F and she was experiencing chills and extreme pain in her left arm. Today, almost 72 hours after vaccination, she is still feeling the same except her temperature is 99 degrees F. She stated that she had been taking Motrin for the inflammation in her arm and headache. I encourared her to increase her fluid intake and to take Tylenol. I also encouraged her to see her physician if symptoms continued after 72 hours.
Pt developed redness & soreness at site of DTAP, then developed uricarial eruption on both forearms approx 48 hrs after vaxs. Pt treated with Zyrtec syrup.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  COAGULOPATHY, UNSPECIFIED TYPE OBSTRUCTIVE SLEEP APNEA
Left arm peri vaccination cellulitis X 6cm with streaks extending toward axilla (lymphangitis).
numbness in my cheeks and top palette,; numbness moved to my jaw bones; Weakness; swelling and redness of face, white around my lip area; immediate pain in the injection sight with  a severe headache; headache; In less 2 minutes dizziness and weakness; redness of face, white around my lip are; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 07Aug2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to food, medications, or other products. On 07Aug2021, the patient experienced immediate pain in the injection site with a severe headache. The headache was never experienced before. In less 2 minutes, dizziness and weakness and the line monitor came to assist to a chair, swelling and redness of face, white around lip area (witnesses provided appears to along with concern) numbness in cheeks and top palette, numbness moved to jaw bones. The patient was afraid and wanted to go home and contacted to doctor and doctor informed not to take the second injection. Therapeutic measures were taken as a result of adverse events and included treatment with ice application to head and neck by nurse. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in the injection site, severe headache, dizziness, weakness, swelling and redness of face, numbness in cheeks and top palette, numbness moved to jaw bones was recovering at the time of this report.