chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. A 66-year-old female patient received at pharmacy PREVNAR 13 (Lot Number M79320, Expiry date 31Aug2017, NDC number 0005-1971-02), intramuscular in the left deltoid at 0.5 ml, single on 28Jul2016 for immunisation.  The patient medical history includes Macular degeneration, Impaired fasting glucose, Allergic rhinitis, Raynaud's syndrome. Concomitant medications includes Age-Related Eye Disease (AREDS) vitamins for eye disorder, Vitamin D for Vitamin D deficiency. On 30Jul2016, the patient experienced burning and itching in area of anterior upper arm (bicep area) but not at the injection site, circular raised rash, redness, all with outcome of not recovered. The patient also developed pain at the injection site on an unspecified date with outcome of recovered. Reporter described the redness and rash as located on the patient's left anterior/lateral bicep, but not at the same location of the injection site. The rash was raised, burning, itching, and circular. The patient has no systemic symptoms, it was only a local reaction. The events required an emergency room or physician visit and received unspecified treatment. Follow up (07Sep2016): New information from a contactable Physician included: vaccine route of administration, exp date, medical history, concomitant medications. Follow-up attempts completed. No further information expected.
Patient presents for concern as above for pain in her left arm secondary to covid-19 vaccine. Has had pain in the arm at site of 1st injection and pain started about 4 hours after the first injection. She did get the second vaccine in the same arm and denies pain getting better or worse after the second injection.  She relates that pain is from her neck to her finger tips. She waited to be evaluated as was told by others (friends) that pain should go away.  Pain is worst were she got the vaccine and in her shoulder. Pain is worse when she is trying to reach behind her back or lift her arm over her head. When pain is worse and present does radiate to her neck and distally down her arm. Denies weakness of the arm. She denies numbness or tingling of her arm of her fingers.  She relates that she did get a fever after the vaccine and a headache but this resolved.  Denies fever now.  Is adamant that she did not have any arm or shoulder pain prior to getting the vaccine.
Temperature for a few hours; Left arm Itchy; Left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE ABNORMAL (Temperature for a few hours), VACCINATION SITE PRURITUS (Left arm Itchy) and VACCINATION SITE SWELLING (Left arm is swollen) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced BODY TEMPERATURE ABNORMAL (Temperature for a few hours), VACCINATION SITE PRURITUS (Left arm Itchy) and VACCINATION SITE SWELLING (Left arm is swollen). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature abnormal, at an unspecified dose and frequency. On 03-Mar-2021, BODY TEMPERATURE ABNORMAL (Temperature for a few hours) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Left arm Itchy) and VACCINATION SITE SWELLING (Left arm is swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: abnormal (abnormal) abnormal.         No relevant concomitant medications were reported.  Treatment for the event includes paracetamol.   Reporter did not allow further contact
extreme fatigue; chills; on and off headache; discomfort on chest; stomach issues; nausea; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), CHILLS (chills), HEADACHE (on and off headache), CHEST DISCOMFORT (discomfort on chest) and ABDOMINAL DISCOMFORT (stomach issues) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced FATIGUE (extreme fatigue), CHILLS (chills), HEADACHE (on and off headache), CHEST DISCOMFORT (discomfort on chest), ABDOMINAL DISCOMFORT (stomach issues), NAUSEA (nausea) and DECREASED APPETITE (no appetite). At the time of the report, FATIGUE (extreme fatigue), CHILLS (chills), HEADACHE (on and off headache), CHEST DISCOMFORT (discomfort on chest), ABDOMINAL DISCOMFORT (stomach issues), NAUSEA (nausea) and DECREASED APPETITE (no appetite) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt c/o swelling of left arm with redness and warmth at the injection site extending to the neck/shoulder area. Pt also c/o knots in left and right side of her neck. States her left hand and left leg are tingly. Thinks she had fever but did not measure.
Received call on 6-27-13 a.m from patient mother that patient had c/o body aches and pain night of 6-26-13 after received MENACTRA vaccine earlier that day. Noted no swelling, no reported fever took MOTRIN patient in clinic on 6-28-13 for PPD reading stated side effects resolved, no reported pain or weakness anymore stated had leg pain/ache and weakness on night of 6-26-13.
a few hours after the vaccine I felt weird. The next morning I had severe vertigo, Could not get out of bed. By 7PM I was able to carefully move around. The small print says it is a possible reaction. I have had many flu shots before, with no problems..2 pharmacists said that , that is not a usual reaction. I am scared to get the shot again.  I would be scared to get the covid shot when and if available. I know 7PM because that is when called me back, and offered my primary Drs. phone number - they closed at 7. Treatment - do not move , watch recorded movies with head stationary on the bed. No food or drink since I could not get out of bed. (FYI) I had the shingles second shot - just a VERY sore arm at injection site (many days) and low grade fever (for one day)  I WOULD LIKE THE REACTION TO BE LISTED AS A POSSIBLE ADVERSE EVENT
Minor headache after second dose.; This is a spontaneous report received from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 25-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced minor headache after second dose of vaccination. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. Therapeutic measures and treatments were not taken as a result of headache. The clinical outcome of the headache was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-JUL-2016 the patient received an improperly stored dose of VARIVAX (lot # L031066, expiry date: 13-JAN-2017). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
he missed the 3rd dose of GARDASIL 9 scheduled April 18, 2020; This spontaneous report has been received from a male patient of unknown age referring to himself. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On unknown dates, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis. On 18-APR-2020, the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product dose omission) due to financial cost.
This spontaneous report was received from a certified medical assistant concerning to a 15 years old female patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv 2 dose  of vax & 3JAN96 lab eval revealed varicella zoster IgG AB 0.08;lab eval on 25JAN96 revealed varicella zoster IgG AB 0.04;no further details were provided
Information was received from a certified medical assistant referring to two unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (lot number L007229, expiration date 03-SEP-2016, dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. Follow up information was received from the certified medical assistant (C.M.A.) via a phone call on 24-SEP-2015. The C.M.A. reported that one of the patients who received the improperly stored (Oka-Merck) PROQUAD (lot number L007229, expiration date 03-SEP-2016) was a 4 years old patient of unknown gender.  The (Oka-Merck) PROQUAD was used on 10-AUG-2015. This is one of the several reports from the same reporter. Additional information has been requested.
I experience a severe headache that made me feel like laying down and I experienced it for about 4 days, going away for good on Sunday (4/25).  But I started experiencing rashes on the back my legs around Friday 4/23, and I still have the rashes. Today is 4/28.
Agitation, fever of 101.6 degrees fareinheit, ache, red injection site, lump at infection site, tingling lips, eye redness.
My girlfriend and I drove on trip. Once we came home our throats were sore, although no one had COVID-19 that we had been around we tested with a home COVID-19 test, my test came back positive. I called my doctor and had a telehealth visit, she called in a prescription of Paxlovid. I started taking the medication that day and within two days I was feeling so much better. I was exposed to COVID-19 in late March, I again tested positive on March 24, 2023. Thank goodness this time it only took four days for me to test negative.
This is a spontaneous report from a contactable consumer, reporting for herself. This 22 year-old female patient received the first dose of TRUMENBA intramuscular in the left arm on 27Sep2016 at 0.5 ml single for immunisation.  Medical history included polycystic ovarian syndrome from Feb2016, Hashimoto's disease from Feb2016, low immunity, headache, fever, sore throat and cold. Concomitant medications included ethinyl estradiol, ORSYTHIA, tablet for polycystic ovarian syndrome, ROBITUSSIN for sore throat, FLONASE, TYLENOL for headache and fever, levothyroxine (100mcg on the weekend and during the weekdays 88 mcg) intramuscular for Hashimoto's disease. The patient experienced bump on arm, red and hard on 27Sep2016. Therapeutic measures were taken as a result of events and included menthol ointment and hot compress, but it did not go away. The patient was recovering at the time of this report. The patient said that she had been having a cold lately so she did not know if having a low immunity was causing the bumps on her left arm.
Pt experienced neck pain, severe headache above both ears, jaw pain radiating down left side in arm that vaccine was given. 2 days later pt experienced lymph node and face swelling. Pt saw her PCP and had already started taking benadryl, tylenol and using ice packs. MD advised pt to continue that regimen and not take her Boniva when it was due but to wait 1 week.
This case was reported by a consumer and described the occurrence of skin sensitivity in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included itchy skin. Concurrent vaccination included TWINRIX (GlaxoSmithKline) given on an unspecified date approximately one month following administration of the first dose of TWINRIX. On an unspecified date the subject received 1st dose of TWINRIX (unknown). Within a few days of vaccination with TWINRIX, the subject skin sensitivity. It was described as the skin being very sensitive to ribbing and even light abrasion. The example was given that after shaving (with an electric razor) the subject noticed several welts on the skin similar to hives. These went away after an hour or so. Since the TWINRIX vaccination, the subject noted several instances where his/her skin at any location would become very red when it rubbed or again raise welts if rubbed hard enough. Again, these persisted for a short duration and then went away. The subject noted that both rash and hives are side effects of TWINRIX and now questions these events as attributable to the TWINRIX vaccination. The symptoms of rash and hives were reported to have started three days after the 1st injection with TWINRIX and have persisted to date (for 3 months). The subject reported taking antihistamines which help with itching, but the skin sensitivity was still present at the time of reporting. It was reported that the skin sensitivity was "perhaps toned down a little." Two doses of TWINRIX were received a month apart and the events continued. It was noted that there were no discernible side effects immediately after either shot (no local soreness or redness).
Began breaking out in a rash that was diagnosed (5 days later) as the shingles. 12 day hospital stay and another 3-4 months recovery at home. Treated with something in the hospital. 07/26/2015 - Patient then broke out EXACTLY ONE YEAR LATER with another set of shingles. Two short stays (Fri-Sun and Fri-Sat) stays this year in hospital.
Redness; swelling and pain right outer arm. It got big quick and has grown in size. No previous incidents.
p/vax pt exp entire lt arm & shoulder became sore;3 days later exp rash 5x2 inches & swelling @ the inj site;no tx given & lymerix was discontinued;
Joint and muscle pain on right side of my body Hip, knee and ankle.  My hip was by far the most affected. If felt like muscle/ligament or tendon.  Was painful to lift my right leg and painful to sit a; Joint and muscle pain on right side of my body Hip, knee and ankle.  My hip was by far the most affected. If felt like muscle/ligament or tendon.  Was painful to lift my right leg and painful to sit a; Joint and muscle pain on right side of my body Hip, knee and ankle.  My hip was by far the most affected. If felt like muscle/ligament or tendon.  Was painful to lift my right leg and painful to sit a; Joint and muscle pain on right side of my body Hip, knee and ankle.  My hip was by far the most affected. If felt like muscle/ligament or tendon.  Was painful to lift my right leg and painful to sit a; This is a spontaneous report from a contactable Consumer (patient).  A 58-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6203), via an unspecified route of administration, in Left Arm on 24Feb2021 at 14:30 (at 58 years) at single dose for covid-19 immunisation . Medical history was not reported. No known allergy.Concomitant medication included ibuprofen (infrequent).  Previously on 03Feb2021 at 14:30 (at 58 years) patient took the first dose of the vaccine (lot EM9810) in left arm for covid-19 immunisation. On 25Feb2021 at 12:00 the patient experienced joint and muscle pain on right side of his body hip, knee and ankle. His hip was by far the most affected. If felt like muscle/ligament or tendon. Was painful to lift his right leg and painful to sit and difficult to get comfortable at rest. He could not lay on his right side. He used ibuprofen and then acetaminophen (TYLENOL). Both helped but the acetaminophen gave more relief. The pain was not unbearable but very uncomfortable. Patient found it interesting that it only affected the right side of his body.Patient recovered on an unknown date in Feb2021. No follow-up attempts are possible. No further information is expected.
Systemic: Abdominal Pain-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe
Rash all over body for three weeks now; started on torso and slowly spread. Itchiness prevents sleeping through the night.
Stomach pain; fever; vomiting; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Dec2021 11:15 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immune Compromised" (unspecified if ongoing); "Phempagus Vulgaris" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE; LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not sure batch, Location of injection: Arm Right, Vaccine Administration Time: 04:45 PM), administration date: 16Apr2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 04:45 PM), administration date: 07May2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Stomach pain", "Fever", "vomiting". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 11:15, outcome "unknown", described as "Dose Number: 3"; ABDOMINAL PAIN UPPER (non-serious) with onset 22Dec2021 18:00, outcome "recovering", described as "Stomach pain"; PYREXIA (non-serious) with onset 22Dec2021 18:00, outcome "recovering", described as "fever"; VOMITING (non-serious) with onset 22Dec2021 18:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of abdominal pain upper, pyrexia, vomiting.  Additional Information: 3rd shot experiences Stomach pain, fever for over 3 days and vomiting. Prior to vaccination, patient has not been diagnosed with COVID-19. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown since the vaccination, has the patient been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858533 same patient/event, different dose of vaccine
I was vaccinated in March was diagnosed Covid; covid; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date in Mar2021 as dose number unknown, single for Covid-19 immunization. The patients medical history included asthma. The patients concomitant medications were not provided. Patient was vaccinated on an unspecified date in March was diagnosed Covid. If patient did not get vaccinated, Doctor said patient would probably be in hospital bed. The vaccine did its job so far. Patient was looking forward to be infused with antibody. The patient underwent lab tests and procedures which included Covid-19 test: positive on an unspecified date (diagnosed Covid Saturday). The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After giving vaccine to patient, within 5mins. Patient started vomiting and her face turned pale. We gave her water and cold pack. 911 was called. Paramedic came and checked on patient. They checked all her vitals and everything was normal. Patient went home with her dad.
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS.The following information was reported: MIGRAINE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Migraine"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "headache"; MYALGIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "muscle soreness"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "body soreness"; LIMB DISCOMFORT (non-serious) with onset 01Apr2021, outcome "unknown", described as "heavy limbs"; NAUSEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "nausea"; DEHYDRATION (non-serious) with onset 01Apr2021, outcome "unknown", described as "dehydration"; PYREXIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "fever".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had a side effect with my two doses of vaccine other than sore arm/; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm). At the time of the report, VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications was provided. No Treatment medications was provided.   This case was linked to MOD-2021-290688 (Patient Link).