chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received 4 vaccines, 2 in R arm Hep A, HPV #1, then 2 in L arm Tdap, & MENACTRA. Pt then fainted & had seizure-like activity. Was coming around & started c/o feeling nauseous & then started c/o throat feeling funny. Sat always 96-97%, vs stable, no difficulty breathing. Epi was given 0.3 mg IM & pt was transported via ambulance to hospital. Given BENADRYL & FAMOTIDINE & sent home on prednisone (oral).
beginning in the evening after the shot I noticed a red area starting to appear around the injection site.  Early in the morning of June 24, approx 1:30 AM I awoke with severe joint and muscle pain over my entire body with a  pain level of 10. I had tears uncontrollably running from my eyes due to the pain. Friday June 25, the muscle and joint pain had dropped to a level of 6 to 7. and I was able to realize that I also was having a severe migraine unlike any I have ever had before. I also notice that I had been having swelling in my hands and feet, dizziness and some cognitive issues. My hands hurt enough that I was unable to make a fist.  The migraine after 4 days dropped down to a bad headache and that lasted 11 days. I still have been having off and on headaches with  them intensifying to migraines and since the shot have had a total of 12 migraine days.  My hands are still swelling and varies from day to day. It has also affected the migraines that I have suffered from and intensified them and changed the location of where I feel the pain. The Chronic Pain that I have been suffering prior to the shot that was 80% under control is now down to 40% controlled and I am having difficulty walking and being able to hold things in my hands. I am afraid that the vaccine has perinatally changed and intensified the migraines and pain issue and regret ever being pushed into receiving it.
Patient reported having heavy menstrual bleeding starting about a week after the shot that did not resolve. She reports still having issues. She will stop bleeding and the next day it will be very heavy and almost fearful enough to go to the ER. She said once it starts it makes her very weak and lightheaded from the blood loss. At this time, she has not been seen for the issue.
Two weeks after booster (dose 3) was given on 6/11/22, pt broke out with hives to arms, legs, trunk; no other symptoms.  Two weeks after second dose given 12/3/2021, pt broke out in hives, had stomach pain, also had swelling to face, tongue, hands and feet, cervical nodes  enlarged.
18JUL pt c/o h/a & stiff neck which then progressed to weakness of back muscles & hamstrings; took to MD on 21JUL94; on 26JUL94 head became weak & so did legs; hospitalized; dx GBS;
Patient stated she had sharp pain in her right wrist a few minutes after getting flu vaccine. Patient called later to state she had some joint pain off and on in her ankles, wrists and arms.
RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing); "sulpha drugs allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient other medication in 2 weeks was unknown. Patient had received anti-viral medication; Paxlovid as COVID 19 Treatment. Treatment started on 13Jun2022 and stop date was 18Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A little bit body ache; Tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 (Lot number: FF2588) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tension Headache" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Past drug history included: Lorazepam for Tension headache, notes: 0.5 mg; Tylenol for Tension Headache, notes: 200 mg. The following information was reported: PAIN (non-serious) with onset 02Sep2021, outcome "unknown", described as "A little bit body ache"; FATIGUE (non-serious) with onset 02Sep2021, outcome "unknown", described as "Tired". Therapeutic measures were taken as a result of pain, fatigue.  Additional information: Patient also had unspecified multivitamins as concomitant medication. Tylenol was taken as treatment of the events.  No follow-up attempts are possible. No further information is expected.
Pt developed redness, swelling, warmth, pain at site of injection- approximately 2 hrs. after injection.
Chills,extreme weakness, diarrhea , fever until 7 am 10/28/2021
first dose given 11/6/07, 11/7/07 Rash on back Dx Allergic vs viral, Sent home from school. 11/29/07 Sent home from school Macules on back off and on. 12/7/07 Pt came for 2nd flu-Nurse noted rash-had provider see pt gave ok for #4. 12/19/07 Rash resolving-Paraflu vaccine
PATIENT WAS VERY NERVOUS PRIOR TO GETTING VACCINATION.  HER DAUGHTER HELD HER HAND DURING THE SHOT.  I ASK THE PATIENT TO REMAIN SEATED FOR 15 MINUTES AFTER THE SHOT. PATIENT WAS ANXIOUS AT THAT TIME AND REMAINED SEATED.  A FEW MOMENTS LATER HER DAUGHTER NOTIFIED US THAT HER MOTHER WAS FEELING VERY ANXIOUS AND TENSE.  PATIENT AS BROUGHT INTO THE CONSULTATION ROOM, AND WISHED TO SIT ON THE FLOOR.  SHE WAS GIVEN A BOTTLE OF WATER TO DRINK. I ASK HER QUESTIONS ABOUT HOW SHE WAS FEELING, IF THERE WAS TROUBLE BREATHING, OR FEELING FAINT.  SHE REPLIED NO, THAT SHE HAD ALWAYS HAD A FEAR OF VACCINATIONS AND THAT WAS THE REASON SHE WAS REACTING AS SHE HAD.  HER HUSBAND WAS CALLED. HE CAME IN SHORTLY. THE PATIENT SAT IN THE CONSULTATION ROOM FOR A FEW MORE MINUTES WITH HER HUSBAND AND DAUGHTER, THEN WAS AMBULATORY AND LEFT WITH HER FAMILLY
Patient had received first dose of Pfizer vaccine. Received 2nd dose with Moderna vaccine today by mistake.
Entire arm (shoulder to elbow) was bruised, arm swelled up to almost 2 x 1 size, very stiff. Pt is also on warfarin so some bruising to be expected.
Information was received from a pharmacist concerning pt who has an allergy to penicillin. Post vaccine pt experienced an injection site reaction. F/U rec'd updated box 24, pt name, dob,date of report, date of onset of adverse event 8/00, date of vaccine administered 8/00.
injection site soar; chills; weakness; muscles sore; it's like I have the flu; I fell crappy all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: injection site soar), chills (Verbatim: chills), weakness (Verbatim: weakness), muscle soreness (Verbatim: muscles sore), influenza (Verbatim: it's like I have the flu) and feeling unwell (Verbatim: I fell crappy all over). The outcome of the injection site pain, chills, weakness, muscle soreness, influenza and feeling unwell were not resolved.   It was unknown if the reporter considered the injection site pain, chills, weakness, muscle soreness, influenza and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, chills, weakness, muscle soreness, influenza and feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAY-2023 This case was reported by the patient via (Shingrix GSK) interactive digital media. The patient received shingles shot and experienced injection site soar, muscles sore, chills, weakness, and was feeling like the had the flu and felt crappy all over. The follow-up could not be possible as no contact details were available.
Syringe malfunctioned after inserting into patient's right deltoid. Vaccinator reports that patient received less than half of the dose. Vaccinator obtained a new syringe and injected a full dose into the left deltoid
Given varicella vaccine 10/30/03. 10/31/03 headache, but played baseball. Hit by baseball on head. 11/4/03 admitted to hospital severe N&V. CT and MRI of brain negative, but CSF positive for pleocytosis-256 WBC and 98% of lymphocytes. Also had R paresthesias. Afebrile.
Friend of patient cam to inform us on her behalf that she was in the hospital with Guillain-Barre Syndrome
While I?ve had mild carpal tunnel symptoms (cts) in both hands, in less than 10 days of receiving my 2nd shot, the symptoms quickly and severely escalated including numbness, pain, sensation of pins and needles, burning sensation, swelling and weakness to the point I sought out medical treatment.  I underwent a nerve study for my cts on both hands, test results showed more severe nerve issues in my R hand even though my system were physically more severe in my L hand. I had cts surgery on my L hand on June 17 and a steroid shot in my R hand on August 20.  To date, the burning sensation and feelings of pins and needles has subsided, but the numbness, swelling and weakness is still present in both hands
10:32 :  FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS:  T:  98.2, P:  72; BP:  LEFT ARM:  150/98; RT. ARM:  152/100.  has hypertension, has not been taking her BP meds for over 1 month.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 20Feb2021 as dose 1, single (Lot number: EL9266), on 13Mar2021 as dose 2, single (Lot number: EN6206) and on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: REMICADE, start date: 20May2022, stop date: 20May2022. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown results, notes: Treatment of COVID-19; (May2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. The patient received "paxlovid" to treat vaccination failure, covid-19. Treatment start date: 26May2022, treatment stop date: 31May2022.
Psychotic episode more severe than has been since I?ve been on an anti psychotic medication. Lasted about an hour until the 6mg of klonopin kicked in and I fell asleep.
night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced NIGHT SWEATS (night sweats). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Mar-2021, NIGHT SWEATS (night sweats) had resolved. Not Provided          Concomitant products included Blood pressure medicine.Treatment medication included Tylenol. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-085406 (Patient Link).
Administered an extra dose of MCV4 to student as registered for by parent.  Student had already received the 2nd required dose of MCV4, so this was an additional, unnecessary dose.  Notified parent by phone of administration of unnecessary vaccine, and advised her that she should contact me if student experienced any side-effects.  No side effects reported as of today.
persistent crying for more than 3 hr; mom related incident to nursing staff a/being given 2nd series;
Was burning up; I slept early and throughout the night; Shivering; Felt very cold; Shaking; Had to turn on the heater; Felt extremely hot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot) and BURNING SENSATION (Was burning up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 OLMESARTAN, ROSUVASTATIN, MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN E NOS], VITAMIN D [VITAMIN D NOS], CALCIUM, VITAMIN C [ASCORBIC ACID], GABAPENTIN and OMEPRAZOLE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (Sore arm). On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot) and CHILLS (Shivering). On 28-Mar-2021, the patient experienced HYPERSOMNIA (I slept early and throughout the night). On an unknown date, the patient experienced BURNING SENSATION (Was burning up). On 02-Mar-2021, MYALGIA (Sore arm) had resolved. On 29-Mar-2021, FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot), HYPERSOMNIA (I slept early and throughout the night) and CHILLS (Shivering) had resolved. At the time of the report, BURNING SENSATION (Was burning up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable.
Within 6 hours- chills, headache Within 24 hrs- sore arm - no swelling at site Within 48 hrs- increased headaches, left eye swollen shut and red, continuing to today?s report
Both legs became tingling/ tingling radiated frombehind knees into calves and upto buttock; Nausea feeling; Uncomfortable to sit for any period of time; Behind knees were slightly swollen; Occasional sharp pain; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included controlled anemia, exercised induced asthma and sensitive to sulfa drugs. 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 vaccination. Concomitant medication included iron supplement (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 20Mar2021 at 08:00 (also reported as 2 days following shot), the patient's both legs became tingling. The patient had nausea feeling and was uncomfortable to sit for any period of time. Behind knees were slightly swollen and the tingling radiated from behind knees into calves and up to buttock. The patient had occasional sharp pain which was only a couple of days. It had been over 6 weeks and still the patient was not back to normal. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date, the patient underwent COVID test via nasal swab and the result was negative. Therapeutic measures were taken as a result of events and included unspecified treatment and urgent care, family doctor, emergency room visit and many tests were conducted. The clinical outcome of the events both legs became tingling/tingling radiated from behind knees into calves and up to buttock, nausea feeling, uncomfortable to sit for any period of time, behind knees were slightly swollen and occasional sharp pain were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Erythema, edema, warmth at shot site that expanded to more than 4 cm and started to track. Extend medially along the thigh. Much larger than typical localized reaction. Minimized on abscess/infection.
This spontaneous report was received from a 72 year old registered nurse(who is also the patient) regarding herself. The patient has arthritis and no drug allergies or reactions. On 27-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included TYLENOL, valacyclovir hydrochloride and HYDROCODONE. On 18-MAR-2013, the patient developed shingles like symptoms. The patient reported that since 18-MAR-2013, she has been experiencing spinal column itching, severe pain in joints and muscles and a shingles like rash with one papule noted on un unspecified area of her back. The patient had been to the physician and was told that she has full blown shingles. The physician prescribed valacyclovir, hydrocodone and TYLENOL to treat the symptoms. The patient reported that she was experiencing less pain after the treatment. There were no laboratory tests performed. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention. Additional information has been requested.
Patient returned to pharmacy about 45 minutes later reporting tightness in chest and throat.  Asked if he should be concerned -- he said his breathing was fine but felt a little flush.  Pulse oximeter 97 pulse 70 bp 138/83 and rpm 16.  Vitals and breathing did not indicate anaphylaxis and could have been anxiety over receiving vaccination.  Patient felt ok to continue home and he did state he had an Epi-pen at home if needed.  Called patient next day --- he reported the tightness lasted a few hours but no worsening of symptoms and he felt fine at that time with just a sore arm .
Papular rash on limbs & torso x 1-2 days (25-30).
PATIENT C/O PAIN STARTING 8 HOURS AFTER SHOT WAS GIVEN. REDNESS ON ARMPIT AND LEFT DELTOID.
Severe diarrhea, autism, development delay, cried for hours, wouldn't sleep, sensory issues - noises and light disturbed/disturb him now, fever and agitation.
Initial Sx - face flushed, SOB, numbness, dry throat, ETC -SOB, hives, itching, redness, bites arms and swelling. Discharge home after 2 hours.  12/04/09 ED received for DOS 11/25/09. DX: Allergic reaction, urticaria.  Pt presented with hives and maculopapular rash on neck and both arms, SOB and dryness of throat, rash, redness, itching and swelling.
I woke up feeling more stuffy than normal so I took a home COVID-19 test and it came back negative. I was tired but the rest of the day was okay. The next day I had a scratchy throat and felt bad so I took the home COVID-19 test again and this time it came back positive. I called my doctor, we had a telehealth visit and she prescribed PAXLOVID. I started taking it the night. I slept through the night and the next day I felt so much better.
immed p/vax skin @ lt thigh became blotchy red; pt not restrained well to use arm for MMR-immediate 5 cm wheal devel w/tenderness & redness; called clinic MD gave DPH subsiding swelling p/10 mins; will not eat; viral infect;
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Diarrhea; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mentioned that "Well I tried going to the website but I can't even go through the website for some reasons, but I had the COVID vaccine on Thursday and I have been expect. I have been having these different things like injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea and diarrhea that different things here on an unspecified date. The patient want to find out how long these stuff was going to last, I mean if it last a few days, or weeks, or what I don't know, that's my question Well if I have any problems I will come back. Outcome of all events was unknown.    The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for six patients. This is the fourth of six reports. A patient (gender, age and race unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history was unknown. Relevant medical history and concomitant medications were unknown.  On an unknown date, the patient experienced irritability and inconsolable crying. Relevant laboratory data were unknown. Therapeutic measures taken in response to event were unknown. The patient recovered after a couple of weeks on an unknown date. Follow-up (06JUN2011): This is a follow-up spontaneous report from the same contactable nurse. The nurse reported that she had only reported on one patient, but had receive five letters, for the same patient, in error. As a result, five cases were erroneously created regarding the same patient. There is actually only one patient and one valid case (201111773).
Mother noticed rash beginning with 3 sores that looked like "mosquito bites" that were above knee. Rash spread to legs, arms, hands, face and back over next few hours. Right eye became swollen and mother stated child complained of general pain.
SWOLLEN ARM PIT GLAND (AUXILLARY) IN SAME ARM AS SHOT, PAINFUL FOR 3 DAYS, SUBSIDED ON 4 TH DAY.  TODAY IS 6TH DAY, JUST SLIGHTLY TENDER. ALL NURSES AND DR'S DENIED IT WAS SIDE EFFECT.