chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got the pfizer covid vaccine and about 10 minutes later when I checked on her, said she was dizzy/lightheaded/had a headache. Before the vaccine she was very anxious. I thought maybe she was going to faint so I asked if she was willing to sit or lay on the ground but she didn't want to. At that point I did offer some water, she drank about 3-4 ounces. I checked on her every few minutes but then she started to have some chest tightness. I consulted with our PCSM and he advised to still monitor. I confirmed with patient she was not having any rash/facial swelling/difficulty breathing. I asked her to wait a few more minutes so I could monitor and told her we have an epipen in case of emergency. About 40 minutes after the vaccine I checked on her again (after checking several times before) and she said she was having trouble breathing. I sat with her a minute to talk to her but some of her responses seemed a little disoriented. It seemed like her symptoms kept getting worse. I then told the mother I was recommending to call the ambulance since she now said she felt like her throat was swelling. I called 911 and they sent the fire department. I told one of the fire department that she received the Pfizer covid vaccine around 8pm. He said that his hunch was that this was more related to anxiety rather than true anaphylaxis and then they took her away on the stretcher. Patient was still breathing and talking and able to answer the questions the fire department was asking.
I have Bronchiectasis and the day after the vaccine I had weakness in my arms and legs and my Oxygen level was at 86-87. I had to go to bed for the whole day. The symptoms lasted for 36 hours. It was hard to stand, hard to walk and hard to breathe. My breathing got a little better over time. My Oxygen returned to about 92 and it improved over a few days. The weakness gradually improved over time and after ten days my strength was more normal. I broke my hip on 07/02/2021 after a fall.
Patient had vaccine and about 10 min after vaccine she developed chest pressure, SOB and feeling of a pounding heart.  Patient was assisted to cart, states that she has panic attacks sometimes while driving, she takes BP meds at home and did not take them today.  Patient now stating that the chest pounding has slowed but it feels like indigestion, chest pressure remains.  EMS called at 11:26 AM
arm pain with first dose, nothing more than that. Hives within 2 hours on left arm after 2nd dose, fever and chills 10 hours after, accompanied with bone pain which ended at 11am the next day. I am almost 2 weeks out from the second dose and I still have joint pain, the most severe is in my hands.
At 1:30 AM on 06/22/2019 I awoke from sleep with extreme chills and 99.9 temperature. temperature went up and down over next 8-9 hours. Temperature would drop each time I would take small dose of Tylenol. Temperature returned to normal in afternoon of 22nd (97.6). Experience dizziness and occasional loss of balance over next 36-48 hours. I was unable to leave my apartment on Saturday or Sunday.  By  Monday morning the 24th I felt fine.
red rash at about 2x4 inch dimension at site of injection. pt  stated painful and sensetive to the touch  Also experiencing Left side of neck and Left  Shoulder pain. Symptoms started 9-13-2021 at night  advised pt to apply  cold pack at site monitor and if symptoms get  worse, seek medical care.
Patient who was currently pregnant received first dose of Moderna vaccine on 19 Jan 2021; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient who was currently pregnant received first dose of Moderna vaccine on 19 Jan 2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Sep-2020 and the estimated date of delivery was 20-Jun-2021. On 19-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient who was currently pregnant received first dose of Moderna vaccine on 19 Jan 2021). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient who was currently pregnant received first dose of Moderna vaccine on 19 Jan 2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Glucose tolerance test: normal (normal) Normal. In October 2021, Pregnancy test: positive (Positive) Positive. In October 2021, Prenatal screening test: normal (normal) Normal. In October 2021, Ultrasound scan: normal (normal) Normal.     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.   Patient is due for second dose of Moderna Vaccine on 16FEB2021. Concomitant and treatment medications were not reported.; Sender's Comments: .
fever of 101 F degrees, splitting headache, severe muscle aches all over the body, mild nausea, sore arm and shoulder for 48 hours
Hair Loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair Loss) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ALOPECIA (Hair Loss). At the time of the report, ALOPECIA (Hair Loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Client was vaccinated for COVID 19.  Denied in writing and verbally that he had received any other vaccines in the past 14 days.  After vaccination with Moderna, it was noted in the Immunization Registry that client had received Boostrix and Shingrix on 3/3/21.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound Covid test and symptoms 6 days after completing paxlovid. Patient took 5 days of paxlovid at full dosage from 16Jul2022 to 21Jul2022 for COVID-19 treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SUSPECTED IMMUNOLOGICAL VACCINE FAILUR; This spontaneous report received from a patient concerned a female of unspecified age. 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: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 29-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) negative.  On an unspecified date, the subject experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was associated with product quality complaint: 90000178328 This report was serious (Other Medically Important Condition).; Sender's Comments: vo  20210461045 -COVID-19 VACCINE AD26.COV2.S--suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I woke up around 03:00AM on 01/03/2023 with a bit of a sore throat so I took an at home COVID-19 test and it was positive. I took a second one and it was also positive. I was away from home, so I went to a local urgent care clinic where they confirmed my results. They prescribed PAXLOVID. I experienced a slight headache, slight muscle pain, and diarrhea. After beginning the PAXLOVID, my symptoms improved. On the morning of 01/06/2023, I took two additional COVID-19 tests, and they were negative, and my symptoms were gone, but I finished the full five days of the PAXLOVID.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
11 year male patient administered expired dose of Tenivac, no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case received from another health professional. This case involves a 11 year old male patient who received 0.5 mL expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6014AB and expiry date: 20-Jul-2020) via intramuscular route in the left deltoid on 17-Aug-2020.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Myalgias; dizziness; headache; fever; chills; This is a spontaneous report from a contactable Physician reporting for herself.  A 50-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284), intramuscular in the left arm on 15Jan2021 15:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot SK5730) on 23Dec2020 at 09:30 AM intramuscular in left arm. The patient experienced myalgias, dizziness, headache, fever and chills on 16Jan2021 12:00 with outcome of recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
diarrhea last 3 days; This is a spontaneous report from a contactable consumer or other non hcp (patient himself).  A 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 30Jan2021 11:00 as dose 1, single and he received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: EL3249) via an unspecified route of administration, administered in Arm Left on 20Feb2021 11:00 (at the age of 86-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure, blood cholesterol increased and COPD from an unknown date and unknown if ongoing. Concomitant medications included lisinopril, omeprazole, sertraline and simvastatin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was lisinopril, omeprazole, sertraline, and simvastatin. Prior and since the vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. On an unspecified date the patient experienced diarrhea last 3 days. Seriousness criteria-resulting in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating and congenital anomaly/birth defect reported as no. No treatment received for the adverse event. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Leg pain; headache; Felt like out of body sounds send shock like sensations; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's wife).  A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6204), intramuscular on 03Mar2021 16:40 (at the age of 64-year old ) as dose 1, single for COVID-19 immunisation.  Medical history was not reported. Concomitant medication included olmesartan from 02Nov2020; zolpidem tartrate from 17Mar2021, diclofenac sodium from 06May2020 , Vitamin B-complex from 25Feb2020; aspirin [ACETYLSALICYLIC ACID ] from 11Jan2020, and a dietary supplement from 06May2020, all for an unknown indication. No prior vaccinations. On 03Mar2021 11:30, the patient experienced headache and went to a neurologist. His headache never went away, it felt like out of body sounds that send shock-like sensations. He went to an ENT and confirmed it was not sinuses nor migraines. He had no relief from headache, and it got so severe he felt like he was going to explode. The patient received Tramadol from 19Apr2021 for leg pain and headache and was then started on gabapentin. The patient underwent lab tests and procedures on an unspecified date, which included, MRI and other tests, all seemed okay. At the time of report, it's been over 4 months, and the events have not gone away, gets worse as day progresses. The events were reported serious due to important medical events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
patient received in improper dose of the vaccine.  Pharmacist failed to dilute the Pfizer vial so patient received too strong of a dose.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hr p/flu vax given & resolved w/in 48 hrs;
6:30 pm on 11/5/21 - vasovagal syncope (no loss of consciousness; resolved after 10 minutes); 9:30 pm on 11/5/21 - paresthesia in arms and legs, pathological laughter, fatigue, injection site soreness, chills/shivering; 7:30 am on 11/6/21 - headache, ongoing fatigue, muscle weakness, chills/shivering, sore throat, intermittent cough, injection site soreness, arm stiffness
The morning after the vaccine the patient reported her entire arm above the elbow on the posterior side (side of injection) was inflamed and hot. There were clear borders around the red area and it was painful. The patient was unable to sleep on that arm (indicating sensitivity to pressure). The swelling did begin to subside daily and was almost completely resolved by 09/06/2019 when the patient presented to the pharmacy to report the AE.
pt recv vax 2JAN98 & day 3 pt started to have a crying spell that lasted 3 1/2hr & the child was inconsolable;
very painful arm from elbow to shoulder first 30 hours also virus feeling and body ache all over also very drowsy  first 30 hours              took tylenol  on the second and third day arm was still sore but felt better all over .  fourth and fifth day arm muscle sore to touch and skin rash in same area no fever at any time
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unknown age, gender and race/ethnicity received 2 single doses of TRUMENBA on unspecified dates for immunization. Medical history and concomitant medications were not reported. The patient experienced an adverse reaction (local) to both doses. Outcome was not reported.
Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash was treated with some medication throat started swelling, mild headache and burning sensation all over body.
4hr after vaccine was administered left eye started to swell and then went down. Right eye swelled, rash on buttocks and a few hives on body.
contracted Covid-19 after having been fully vaccinated by the Pfizer vaccine; contracted Covid-19 after having been fully vaccinated by the Pfizer vaccine; This is a spontaneous report from a contactable Consumer. A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 Immunisation. The patient medical history and concomitant medications were not reported. Patient did not have covid prior to vaccination and no other vaccine was given in four weeks. The patient had tested covid post vaccination. It was reported that contracted covid-19 after having been fully vaccinated by the Pfizer vaccine on 01Sep2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 01Sep2021. No treatment was received for the events. The outcome of event was recovering.  Information on the Lot/batch number has been requested.
By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all night. By am I was dizzy once, Achey all day, no energy. Slept all day. Today, dizzy again for a moment. Headache when I woke up. No energy, abit Achey. Not as bad.
Upper arm began to swell the day after immunization - painful, edematous to almost twice size of normal. Red, very hot to touch.
I had a "heavy" burning sensation in my throat, chest and lower back.  I had "sharp" pains in my chest and lower back.  I also had  a "heavy" feeling on my chest feeling similar to compressions (cpr) and my throat felt like someone was physically strangling me.  My throat felt very tight.  This event woke me out of my sleep at 3:38am on Saturday, 11, 2021.  The first 30 minutes was the worse.  It was close call to driving to the E.R. or calling 911.  (I reported this to The Occupational Health Dept. where I received the vaccine).
Mom report post vaccine's about 4-6 hrs later baby became fussy, irritable - no fever. Then noted baby became lethargic (baby not limp) but color very pale - yellow-shallow look. Gave tylenol 20-30 min, post tylenol - symptoms totally resolved and seemed normal there after no vomiting, no diarrhea.
Information has been received on 07/11/02 from a published literature article(Transfusion support with RBCs from Mk homozygote in a case of autoimmune hemolytic anemia following diphtheria-pertusis-tetanus vaccination. Transfusion 2002; 42 (5); 567-571) regarding a 1 month old female who received her first injection of diphtheria-pertussis-tetanus vaccine. Five days post-immunization, she was hospitalized with a diagnosis of autoimmune hemolytic anemia. Prior to admission, she had a 2 day history of lethargy, irritability, occasional vomiting and pallor. On admission, she appeared to be in acute distress with pulse of 160 beats per minute, a respiratory rate of 48 breaths per minute, a systolic blood pressure of 80 torr, and a temp of 37.2 deg C. Lab results included a hematocrit of 9.4%, a white blood count of 21,900 per uL, and a platelet count of 928,000 per uL. A peripheral blood smear revealed moderate nisocytosis, poikilocytosis, polychromatophilia, and spherocytes. The LDH was 477 U per L. The reticulocyte count was 3.3 percent. hepatoglobin was zero. Total Bilirubin was 2.7 mg per dL, and her creatinine was 0.3mg per dL. Complement levels (C3, C4, and CH50) were normal. A standard cold agglutinin titer was less than eight. Marrow examination revealed erythroid hyperplasia. The direct antiglobulin test was positive (3+) with anti-3C only. Antibody detection and identification tests showed her serum reactive (3+) with all red blood cells tested at all phases. The direct antiblobulin test and antibody detection test had been negative at birth. Treatment included daily transfusions and/or exchange transfusions for 3 weeks with whole blood, frozen red blood cells from an Mk homozygote, and red blood cells from a donor homozygous for Mi. VII. Other treatment medications included Solu-Medrol, intravenous gammaglobulin, and Cytoxan. Six months after the initial presentation, she recovered. The reporter indicated that there was a temporal relationship between the event and DPT administration. The literature article is attached to the regulatory form.
Swelling @ injection site left shoulder on 3/7/20. Sore & red dropped into elbow area. Now redness & swelling gone 5 days after MCV4O #2 vaccine. Swelling minimal around elbow. No pain
She still has a red plaque on her arm today, there is a swelling with it; There was a little pony knot where the injection was, and it was red; it is like elongated about 2 inches, an inch and a half to 2 inches long and maybe 3 quarters of an inch wide; Swelling of the node; It's just a little puffy now but there is like a little knot, It's not tender but it's just too red."; This is a spontaneous report from a contactable consumer (patient sister). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN5318) via an unspecified route of administration at upper part of her right arm on 10Feb2021 as a single dose for COVID-19 immunisation. Medical history included thyroid removed and blood pressure. Patient takes 5 or 6 of concomitant medications (cannot pronounce half of them), takes blood pressure medication and medication for she had a thyroid removed. On 10Feb2021, the day after the shot there was a little pony knot where the injection was, and it was red and thought that's okay but it had stayed red and the area, the whole width of it is like elongated about 2 inches, an inch and a half to 2 inches long and maybe 3 quarters of an inch wide. On an unspecified date in 2021, patient still had a red plaque on her arm today, there was a swelling with it. It has been 9 days since the shot, and were wondering (incomplete sentence). The swelling of the node was probably, she had it on Wednesday so probably she had the swelling on Thursday a little on Friday. It's just a little puffy now but there is like a little knot. It's not tender but it's just too red. Patient was not treated for events. Outcome for the events were unknown. Second dose was scheduled on 03Mar2021.