chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, flush, feverish, chills 1/23/21 headache, irritated throat, chills, feverish, rash, night sweats, swelling hands and feet, fatigue  1/24/21 itchy throat, rash, headache, chills, feverish, flush, swelling hands and feet 1/25/21 rash, irritated throat, headache, chills, feverish 1/26/21 mild rash, headache, chills, feverish 1/27/21 chills, feverish, mild rash 1/28/21 itchy throat, flushed, itchy, rash on entire body, feverish 1/29/21 mild rash, chills. 1/30/21 flushed and itchy, itchy throat, chills, feverish
Pt experience facial edema, eye swelling. No SOB, no difficulty swallowing. Tx at hospital Ed with BENADRYL and PREDNISONE.
Within 1/2 hour arm became painful and swollen at site.  The swelling continued and spread from shoulder to elbow over the next 24-48 hours.  Patient contacted an on-call physician and was prescribed Omnicef with 3 doses.  About 18 hours the swelling almost totally resolved still had muscle tenderness.  No fever.
This spontaneous report as received from a medical assistant refers to her 4 month old son, who on 06-OCT-2016, was inadvertently administered a dose of GARDASIL (dose, route and lot# were not reported) instead of PEDVAXHIB. No adverse effect reported. No further information was provided. No product confusion occurred. Additional information has been requested.
Patient presented for 2nd dose and reported having a blood clot the day after receiving her first dose.  She is unsure if it was due to the vaccine or her vascular malformation.  She did not seek medical help or receive a diagnosis from a medical professional.  States the clot dissolved on its own.  Pfizer Covid vaccine
rash on lt thigh in area vax was given 3 x 4 cm area of vesicular rash w/o erythema;
child had a seizure last night. Temp 101.8 seen at hospital. Dx: Febrile seizure. Had WBC cx of 183 Given Rocephin and Tylenol
On 10/27/09 Pt presents after flu shot achy, hot and cold, sore throat, nausea, fever. On L arm she had an indurated 4 cm area pinkish without clear edges. Labs showed Na 134 L shift WBC high nl and Anemia. Pt said she felt better on 11/3/09. 11/4/09 admitted with pneumonia.
Fussiness in the afternoon on 01-04-2021 and trouble falling asleep after  receiving vaccines, with fever of 101F. In the morning on 01-05-21  MOM found that his lips and nose were blue. She quickly stirred him  awake & his color returned to pink in under 30 seconds.  Seen in clinic 01-05-2021. exam reassuring. patient is well  appearing and hydrated.
I think I might have had a mini stroke yesterday. my blood pressure was over 200, I was in the kitchen making soup when it started and I stopped what I was doing and went to the front room to sit down. My chest felt so full. I got up and went and got my BP. It's been as high as 219 and more. Mini strokes. Appointment on the 8th with cardiologist. Had an MRI and echocardiogram about a week ago. They can't figure out why I'm having them. I had another mini stroke today 3/3/2022.
Beginning one day after injection profusive erythema and induration around injection site. Spreading to shoulder and neck. Admitted to hospital. At consult-not cellulitis, probable inflammatory reaction. Antibiotics. Discharged home on 1/22/07. 02/15/07-records received and reviewed for DOS 01/20-01/22/07 DC DX: Cellulitis at injection site right arm In ER Swelling at injection site positive axillary lymphnodes. No fever, itching or chills. Consultation exam:Right arm swollen and firm with faint erythema in the upper half extending to the upper lateral chest wall. Slight tenderness, no axillary or epitrochlear lymphandenopathy. Impression cellulitis versus allergic phenomenon. Narrow to vancomycin.
Initial unsolicited case received from a healthcare professional (office person medical assistant) on 07 Jun 2018. This case involves a patient (age and gender not reported) who was vaccinated expired dose of ACTHIB (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. It was an actual medication error case due to Expired vaccine used. 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. List of documents held by sender: none.
Severe headaches, vomiting, dehydration, shortness of breath ... led to trip to Emergency Room at Hospital on 1/16/21 at 10:45 am; diagnosis for treatment was Diabetic Ketoacidosis (DKA);  patient was admitted to ICU to address critical fluid and electrolyte imbalances , headaches, body aches, dehydration, nausea, shortness of breath.  DKA is medical emergency.
Patient had a rash in the arm where the shot was given in march. Patient started having heart problems in April. Patient said she went the ER was sent to see a heart specialist.
Whereas arm pain from the first two shots was not felt until later that day and went away in a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Jan2021 (Lot number: EN5318) as dose 1, single and intramuscular, administered in arm left, administration date 20Feb2021 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Whereas arm pain from the first two shots was not felt until later that day and went away in a couple of days". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Whereas arm pain from the first two shots was not felt until later that day and went away in a couple of days, the pain from the booster was immediate and severe. The ongoing pain from this incident has restricted her weight-lifting regime which she used to maintain her health and strength. It disrupted her sleep each night and limited her daily activities. No follow-up attempts are possible. No further information is expected.
It started with a bad sore throat and sore ears. They said there was no infection going on and treated it with sinus medication.  The next week it had developed more into a cough.  I went back to the doctor, and they said it had not developed into a bacteria infection. I saw my regular doctor and she said it was an infection and prescribed antibiotics.  I have had a chest scan and waiting on the results.  I have a CT scan schedule for next week.  The cough has become worse.  I feel feverish and my balance is off.  The coughing so hard I have a sore abdominal area.  I am also sore in my chest as well.
she said she has been really sick; I am so sleepy, I sleep all the time; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced she said she has been really sick; I am so sleepy, I sleep all the time. Patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 09Feb2021. Since then, she said she has been really sick. Patient wants to know what would happen if she does not receive the 2nd dose, and if the vaccine would still be effective if she only receives 1 dose. Patient stated, May I ask you a question if I have. Patient got the vaccine on the 9th on February (not clarified) and I have been really sick since then. Patient was wondering what happens if I don't get the second shot. Patient stated, If I don't fall asleep, I am so sleepy, I sleep all the time. LOT: Patient stated, I don't know. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
About 9 hours after receiving my vaccine and feeling fine until that point, I became suddenly dizzy, nauseated, pale and clammy, and felt pressure in my head, my vision became tunnel-like, and I nearly fainted in the span of 1 minute. My spouse prevented my fall, helped me sit down and got me water. After about half an hour later I had recovered from almost fainting, but experienced moderate headache, nausea, muscle aches and fatigue for the following 48 hours.
One week after the injection I have a large (tennis ball sized) raised red spot on my arm near the injection site. This red spot is tender and warm to the touch. It does itch at times but not consistently. It has grown since I initially noticed it.   I am treating it with topical cortizone cream and ice. Possible antibiotic treatement if symptoms do not improve within the next few days.
Mom informs us that pt developed a temperature of 104F on the evening of 2/22/01. Had a seizure that required mouth to mouth and ambu bagging. Reports stable HR this morning.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-APR-2018, the patient received an expired dose of ZOSTAVAX (lot: M038864; expiry date: 25-DEC-2017) subcutaneously (dose not reported) (expired product administration). The vaccine was reconstituted with a sterile diluent (manufacturer unknown) (co-suspect drug). No adverse effects reported.
Post vax the patient awoke from with nausea and vomiting. When the patient went to the bathroom, he became very dizzy and blacked out. The patient complained of left arm pain. The patient was treated with ibuprofen.
Patient experienced facial flushing and vertigo five minutes after Td vaccine was given. Patient responded to Benadryl.
Chills after 6hrs  Fever 102F after 24hrs Body pain radiating in right arm and leg n thymus area
02/16/22 presents to ED for "sore throat and shortness of breath". PMHx of "paroxysmal atrial fibrillation, CAD, ex-smoker"
Breakthrough COVID infection on 6/10/2022. Tested due to known exposure. Patient denies respiratory symptoms
The patient received the flu vaccine at approximately 1:21PM on 10/22/2021. I was the immunizing pharmacist and at the time of immunization the vaccine procedure went smoothly and the patient did not complain of any pain at that time. The patient stated he contacted the pharmacy on Saturday 10/23/2021 and explained that he is having numbness, tingling and pain when he lifts the arm the immunization was given in by the elbow. He says the pain began on the evening of 10/22/21. The pharmacist had instructed the patient to try some at home techniques to resolve the pain and suggested he seek care if he was still in pain. The pharmacist left a message for me to follow up with the patient on Monday 10/25/2021. I contacted the patient on Monday 10/25/2021 at about 5:30PM. He said the pain and numbness has not improved since the evening of getting his vaccine. He stated there is no redness or pain at the injection site. I discussed with him his concomittant heart and diabetes issues and told him I would contact his PCP 10/26/2021 and follow up with him. I suggested he ice the arm for 15 min increments and take naproxen or TYLENOL for pain. I explained it was important to not take too much naproxen due to his heart issues but for temporary relief it may help. I will call his PCP in the morning.
This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 69-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On 1st June 2018, less than a year after receiving SHINGRIX, the patient experienced pruritus. On 1st July 2018, the patient experienced raised rash. On an unknown date, the patient experienced cough and sleeplessness. On an unknown date, the outcome of the raised rash and pruritus were not recovered/not resolved and the outcome of the cough and sleeplessness were unknown. It was unknown if the reporter considered the raised rash, cough, pruritus and sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The health care professional said that the patient stated that they had experienced hacking cough that started after administration of SHINGRIX and this hacking cough is keeping the patient up at night. At the date of reporting, pharmacy said that the patient went into the pharmacy today to show her this side effects. The pharmacist said that the bumps were in his right hand and on his back. The patient did not mentioned any other issues to the pharmacist. The patient had not reported this reaction to his physician.
Sudden onset of weakness and extreme light headedness. Avoided fainting by putting head between legs. Became very weak. Had to leave the appointment I was at and go home. Became very fatigued and temperature went up to 99.5. All symptoms came out of nowhere. There was no feeling bad or strange before onset.
Sudden onset  fever, uncontrollable shaking , chills, intense headache and intermittent ache in chest  Fever broke after a day and a half, still lingering as low grade headache still lingering even with taking a headache pain reliever every 4 hours.  Body still dehydrated even with drinking massive quantities of water.
Pain on left side with tingling, Shingles, Antiviral Valtrex, Nerve pain Gabapentin, and Zyrtec for treatment.
Rash on legs and torso and wheals measuring 5-8 cm on both legs and she had a few on her arms and one on her face.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-NOV-2012, the patient was vaccinated with the first dose of PNEUMOVAX 23 (route of administration, lot number and expiry date were not reported). Subsequently on 16-AUG-2016, the patient was vaccinated with the second dose of PNEUMOVAX 23 (route of administration, lot number and expiry date were not reported). It was reported that, the patient was not indicated for a 2nd dose of PNEUMOVAX 23 to be administered. No adverse effect was reported. Additional information has been requested.
After GARDASIL #3 Pt. c/o stomach pain after 2 days mother report her daughter is doing fine.
tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 15:05 (Lot Number: ER8734) as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient tested positive for COVID-19 on 20Apr2021. The patient's husband asked if patient should go tomorrowto get her shot? She has her appointment for the second dose on 22Apr2021 and now she wants to know if she should cancel? Adds when she got the vaccination she felt normal and she thinks that vaccine has helped. The events did not require a visit to emergency room or physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was unknown.
Brain Fog, concentration problem with scattered thinking and anxiousness---still resolving. [Vertigo, dizziness and movement issues]- this section lasting for 1 day
Narrative: Patient received two doses of covid vaccine. PMH of hx of Lung CA, BPH, HTN and g-tube for feedings. Patient was on HBPC and declined, refusing hospital care and requesting to go to hospice. No other details of death reported. reporting per instruction.
Event: voice changed was reported as worsened.; voice changed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 03May2021 (Lot number: ER8736) at the age of 44 years as dose 2, single and administered in arm, administration date 12Apr2021 14:30 (Lot number: EW0150, Expiration Date: Jul2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious) with onset 13Apr2021, outcome "not recovered", described as "voice changed"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Event: voice changed was reported as worsened.". Additional information: The patient was calling about the covid vaccine. The patient had the second dose yesterday, 03May2021. When the patient got first dose, the next day her voice changed it went up and down and stuff. The caller thought it was a side effect of the covid vaccine, but it was no big deal. The patient got her second vaccine and was fine this morning and then about the same time as last time, the voice change started again. This voice changing event happened with the first and second dose of the vaccine. First dose event lasted about 2 days, maybe a little bit more than that and then it went right back to normal. Second dose event started today, 04May2021. The patient described it as ongoing and worsened. No additional Vaccines administered on same date of the Pfizer suspect. The events did not require a visit to emergency room or physician office. No prior vaccinations (within 4 weeks)/ events following prior vaccinations. No patient medical history. No family medical history relevant to events. No relevant tests.  No follow-up attempts are possible. No further information is expected.
Had Hep B #3, Tuesday 3/20/01. Woke up at 02:00 AM with vomiting and diarrhea. By morning, was vomiting blood and having bloody diarrhea. Pt went to ER. Dx'd with Gastroenteritis (mom stated It's a very contagious virus).
After 24 hr recieveing Anthrax #2 vaccine, large local induration/edema/erythema/pain to r arm, max size 13in x 8 in. took Benadryl/Motrin on day 2, by day 4, symtoms resolved
rash on her thigh; very sore arm; she feels worn out; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (Patient herself) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not provided), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant was not reported. After receiving first dose of vaccine, patient reported that she experienced a rash on her inner thighs and event was better for next day morning, but she woke up during the night with a very sore arm and she felt worn out for next day morning. The outcome of the events rash was recovering and felt worn out, very sore arm events outcome was unknown.  Information on the batch/lot number has been requested.
SHORTLY AFTER THE INTIAL INJECTION, MY BOWEL FREQUENCY AND FORM, GOING FROM SOLID TO SOFT AND LQUID.  IT GRADUALLY BECAME MORE FREQUENT UNTIL I SAW A  GASTROENTEROLOGIST.  I AM NOT A DIABETIC, I AM NOT AN ILICIT  DRUG USER, I AM NOT ALCOHOLIC (AN OCCASIONAL BEER) BUT I EXHIBIT THE SYMPTOMS OF PANCREATITIS, OR EPI. THERE IS ABDOMINAL PAIN THAT RADIATES TO THE BACK (BUT NOT ALWAYS); THERE APPEARS TO BE FAT  ORANGE IN COLOR STOOL, WITH STEATORRHEA  WITH A FOUL SMELLING FLATULENCE. I HAVE LOST 15 POUNDS
itchiness; Redness; warm to touch; Swelling; COVID arm; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm to touch), SWELLING (Swelling) and VACCINATION SITE REACTION (COVID arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02AL20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Osteoporosis since an unknown date. Concurrent medical conditions included Drug allergy (cipro allergy) and Drug allergy (Levaquin). Concomitant products included OLMESARTAN from 15-Aug-2018 to an unknown date for Blood pressure high, DENOSUMAB (PROLIA) from 01-Jun-2018 to an unknown date and CALCIUM for Osteoporosis.   On 17-Jan-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 24-Jan-2021, the patient experienced PRURITUS (itchiness), ERYTHEMA (Redness) and INJECTION SITE WARMTH (warm to touch). 24-Jan-2021, the patient experienced SWELLING (Swelling) and VACCINATION SITE REACTION (COVID arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Feb-2021, PRURITUS (itchiness), ERYTHEMA (Redness), INJECTION SITE WARMTH (warm to touch), SWELLING (Swelling), VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Medical history includes hypertension and osteoporosis.   This case was linked to MOD-2021-080783 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added in patient tab: Levaquin drug allergy.Added information product tab: Batch number and anatomical site.
SIX weeks after second Moderna shot I've had a mild recurrence of Shingles despite having had both the Shingrix and Zostavax vaccines. My only other occurrence was 6 years ago which was after Zostavax, but before Shingrix. Just thought you should know.