chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in arm after vaccine administered; soreness spread across chest at approx 2000. Awakened at 2200 with heavy/crushing midsternal chest pain with radiation to neck & both arms.  Relieved after approx 30-40 mins (took Tyl).
Headache chills fever body aches lump in throat nausea followed by pneumonia low oxygen level very high white blood count
Mom states pt had inc fever 103-104, really fussy; pt taken to MD & was instructed by MD not to give DTP to given DT only;
Received COVID Vaccine on 03/14/2021. Pt had body aches and fatigue but on 03/17/2021 started with itching, pain on lips, forehead and waist line.  Patient has lesions and significant pain consistent with shingles.
On Wednesday I got my booster on Friday about 7pm. I was all of sudden hit with very bad vertigo and vomited several times. Only way to get relief was to go to sleep. Lasted about 4 days. After that, it happened occasionally for the next several months. Since mid-February the episodes have decreased, and I take prescription meclizine I have taken 1/2 pill for dizziness. In addition, my right ear on the same Friday, began started ringing - right ear - and now have hearing loss. I have not recovered from this. The ringing continues. I took a 12-day pack of prednisone in December.
Pink red spot about 2 inches wide. Hot and red to touch for about 4 days. Patient did not treat.
Vaccine administered beyond 12 hour usage time frame, approximately 8 hours beyond the use time frame. no reports of adverse symptoms, reaction, or associated symptoms.
After vaccine given mom then tells RN patient had the chicken pox.  RN explained he may have some reaction to vaccine and if she had told RN or Dr this.  He would not have been admin. @ 0600 7-17-09 mom called this RN @ home reported patient was c/o not feeling well.  Had fever of 100.9 oral.  Emesis, headache.  Had given ASA.  RN instructed not to give ASA again.  Give cool bath, push fluids if not feeling better by 0830 to call medical office for appt (see back of form).
pt said 48 after she got the shot, she experienced severe anaphylaxis reaction. she had body , face. lips swelling, trouble breathing . She was transported to ER and  stay there for about 10 hours.
Mom called 10:40 on 8/4/03 stating that on 8/3 while child drinking bottle "not acting himself" looking like falling asleep, eyes rolling back, then shook for a a couple of seconds (per Mom) then fell asleep, whole body shaking for few seconds. 8/5 checked by nurse practitioner-doing well-scheduled for EEG.
Bad headache, chills, low fever night of injections.  Followed by 2 days of major fatigue and brain fog.
I fainted; today she is feeling kind of drunk; having trouble keeping in balance; Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time; Today I started feeling miserable,; I had general weakness; malaise; dizziness; disoriented; confusion; I threw up; I had severe nausea,; I had muscle aches and body aches; My arm was hurting the next day; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (I fainted) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL and GABAPENTIN for Fibromyalgia.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm was hurting the next day). On 27-Mar-2021, the patient experienced SYNCOPE (I fainted) (seriousness criterion medically significant), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches). At the time of the report, SYNCOPE (I fainted), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), VACCINATION SITE PAIN (My arm was hurting the next day), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Treatment information included Ondansetron, Ibuprofen.
sars-cov2 infection; 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 73-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand unknown and Vaccine dose number unknown: False, Vaccine lot unknown: True, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Vaccine brand unknown and Vaccine dose number unknown: False, Vaccine lot unknown: True, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion), on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic kidney disease stage 3B" (unspecified if ongoing), notes: Other medical history: chronic kidney disease stage 3B; "asthma" (unspecified if ongoing), notes: Other medical history: asthma; "COPD" (unspecified if ongoing), notes: Other medical history: COPD. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), outcome "not recovered", described as "sars-cov2 infection"; VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Treatment of COVID-19". Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer Paxlovid, Treatment start date: 16Jun2022, Treatment stop date: 20Jun2022, Indication: Treatment of COVID-19. Adverse event: five days after stopping the medicine, COVID symptoms came back, Adverse event start date: 02Jul2022, Adverse event start time: 03:00 PM. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, vaccination failure. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Vomiting 2 hrs p/immun then cont 5-6x/days for 2-3 days; Mom reports t102 R, very fussy; given APAP; Taken to MD observed overnight; MD felt rxn to vax;
Itching; Bulls eye rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching) and RASH (Bulls eye rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bursitis. Concomitant products included MELOXICAM for an unknown indication.    On 16-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PRURITUS (Itching). 16-Jan-2021, the patient experienced RASH (Bulls eye rash). At the time of the report, PRURITUS (Itching) and RASH (Bulls eye rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swelling 2 inches around shot area; thickening of skin; 1/4 inch radius redness; pain for 5 days; sensitive to touch for couple of days but not unbearable.
PATIENT HAD PREVIOUSLY RECEIVED PFIZER COVID VACCINE ON 4/28/21
Left arm 6A next day ring finger pinky finger tingling. Light tingling from shoulder to fingers. Redness around site.
Few hours after vaccine injection she developed a pearly pink/red popular rash on extremities (distally) and tops of ears. Itchy.  Started left distal forearm then noticed on the other areas over 3 days. No rash or redness at the injection site.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 06 Oct 2021, Both 5.5 ml and 7.5 ml vials were received in partially thawed/liquid condition vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 8 degree Celsius, total duration of the excursion refrigerated temperature for maximum of 4 hours.  No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-496015 (Patient Link).
patient felt as if he was having an asthma attack following vaccination. he denied chest pain. no cough.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored oral, ROTATEQ lot t# K010325, expiration date: 10-MAY-2015 and lot # K023537, expiration date: 22-JUN-2016 (dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
19 month old boy with 103 that started on 07/27/04. Has red pinpoint macular rash on trunk and arms. No vesicles. No petechiae.
Left arm redness, itching, swelling, discomfort, welts.  Treated with ice and ibuprofen.
Sx from 11/05/2008 through 11/06/2008. Client had c/o fullness, pressure, and pain in (L) chest area. Sx increase when lying down or bending over. She denies any SOB, irregular HR, or edema. All Sx resolved by 11/07/2008.
immediate fatigue/in early evening and through the night, chills and shivering/severe body pain/initially warm but soon was burning up (never thought to take temp though)/ not very  hungry ---trouble walking and with balance, so I needed to walk with a cane or hold on to  things and it took a great deal of effort to walk / visully things didn't look normal, almost as if dizzy since they were spinning /vertigo ----I walked with a cane for about 3 days and didn't  feel quite "normal" for a week.
Guillain-Barre; This is a spontaneous report from a contactable consumer or other non HCP. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date the patient experienced Guillain-Barre. The outcome of the event was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (09Nov2021): This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Pt. had allergic reaction to right thigh DTap & PREVNAR given on right thigh. Turned red & swollen 3-4 hrs later. Red, feverish, hard & swelling 1/2 dollar size.
My wife and I had just returned from a cruise, I started having a cough. The cough persisted, and I just started not feeling right, my throat started to hurt, my chest and sinuses started to hurt. I took a home COVID-19 test, it came back negative, I took another test the next day it also came back negative. I called the local clinic to let them know my symptoms, the ordered me an antibiotic and decongestant. Later that day I took another COVID-19 test and it came back positive. I called the local clinic back to update my test results they called in a prescription of PAXLOVID. The first day I didn't feel good at all, I was so tired, and my throat hurt so bad, it took a full five days to feel better. I do still have lingering cough, but I am feeling better.
Itching and burning rash all over body. It has been 3 weeks since it started and it is still not gone. It started 2 weeks after I got the booster shot.
Pfizer-BioNTech COVID-19 Vaccine EUA she has had persistent fevers, chills, sore throat for 10 since vaccine, not abating.
Weight gain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain) and PYREXIA (Fever). At the time of the report, WEIGHT INCREASED (Weight gain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) Increased.         No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID 19 Vaccine trial.  No treatment information was provided.
After the second dose sweeping in glands in opposite side of neck, throat and up to ear/Swelling in lymph nodes in axillary; fever; sore throat; This is a spontaneous report from a contactable Nurse. A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En9581, Expiry date not reported) via unspecified route of administration, administered in left arm on 13Feb2021 (at age of 38-years-old) as dose 2, single for COVID-19 Immunisation. The patient medical history includes Polycystic ovaries (PCOS) and COVID-19. There are no known allergies reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: El3248, Expiry date not reported) via unspecified route of administration, administered in left arm on 30Jan2021 at 09:00 (at age of 38-years-old) as dose 1, single for COVID-19 Immunisation and experienced swollen lymph nodes in arm of vaccine ancillary and basilic. Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient received Birth control within two weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient had tested for COVID-19 post vaccination with nasal swab. On 09Mar2021 at 12:00 (24 days 12 hrs after vaccination) After the second dose patient experienced sweeping in glands in opposite side of neck, throat and up to ear. Swelling in lymph nodes in axillary fever a month later and sore throat. Adverse Events resulted in doctor or other healthcare professional office/clinic visit. The Patient received treatment for adverse events with tested again and given Tamiflu. The Patient underwent lab test and procedures include nasal swab test result was unknown on 09Mar2021.The Outcome of the events was not recovered    No follow-up attempts are possible. No further information is expected.
Tested NAAT positive for COVID 11/3/21 after being fully vaccinated.
RIGHT DELTOID AREA SLIGHTLY BRUISE ERYTHEMIA 8-10 CENTIMETERS CIRCUMFERENCE
Grandmother noticed redness and swelling on 05/27/2003 and states it worsened on 05/28/2003.  On 05/29/2003 appears the same.  Reddened, swollen area which measures 80 x 80 mm.  Treatment-using ice packs.
Blister like rash on abdomen and back, very itchy. Probably varicella.
After 6 days that I took the first dose of pFizer vaccine for covid19 I had itchy skin. Stared on my chest, then pass for my belly and back.
Later in day after receiving flu shot, redness lower area where shot was given, approximately 3" x 3" area marked. 12/14/12 at 1315, pt to observe & report increase in symptoms, felt bad yest (chills), T 97.9 (T) today.
Through telephone Spanish Interpreter, spoke with patient. Per patient on 6/29/2021 received 2nd dose of COVID 19 vaccine and on 6/30/2021 started having symptoms: fever and headache. On 7/2/2021, started having more symptoms: burning facial rash, pain in feet, back, muscles, joints, back and fatigue with intermittent dizziness. Per patient went into a Clinic and was instructed to go back to vaccine site. Per patient tried taking Ibuprofen and no resolve of symptoms from medication. Patient does not have a PCP, so PHN suggested that patient should go into a hospital emergency room. Patient verbalized understanding information provided by the PHN via TC. And plans to follow up with ER today.
Pt received Tdap yesterday at clinic. Pt stated she developed hives to face and extremities, no difficulty breathing or resp distress.
Received Pneumovax 23 pneumococcal vaccine polyvalent at 11:30 AM in right arm.  By 3:00 was having a lot of pain and stiffness and by 9:00 PM extreme pain and could not raise the arm, sit, or lie down.  This extreme nerve "zinging" continued for about 8 hours and the arm could not be lifted at all, I had to hold my hand and pull it out a bit to put a bra under the armpit(husband had to fasten), could not comb hair, etc.  Any motion sent pain through the arm and shoulder.  I slept with my arm propped up on a folded pillow for over a month if I was in bed.  I often slept in a lazy boy if it had a left-handed foot control as I couldn't run anything with the right hand.  I began to be able to move the arm a bit after about a week.  For a month I couldn't lift arm above shoulder and not hold any weight with the right hand.  I was eventually able to put on makeup and lift the arm enough to curl some of my hair.    I had about four weeks of physical therapy and regained a bit of movement each time.  After four months, the arm still aches when I am lying down to sleep, I often have to change positions or get up and sleep in chair.  The arm still doesn't feel good if I reach towards the back at all and aches from shoulder around the back and to the elbow.
Patient described severe itching at injection site and  rash was at the injection site. The patient went to the doctor and was prescribed generic Bactrim for 10 days. Patient has been extremely tired.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female. Initial information was processed with the additional information received on 26-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no known allergies and did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient had a COVID symptoms of bowel issues and a sore throat after being exposed to a friend/coworker who tested positive on 19-AUG-2021 while on break without masks (suspected clinical vaccination failure and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191140.; Sender's Comments: V0: 20210852508- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS