chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I HAD THE FIRST VACCINE DONE 8/17/2021 NO SEVERE REACTION. I ONLY HAD A SORE ARM. ON 10/2/2021; I HAD THE SECOND VACCINE DONE ON THE SAME ARM. THE NEXT DAY, ON 10/3/2021; I AWOKE TO PAIN UNDER MY LEFT ARMPIT! (LYMPH NODE AREA.) I CALLED MY IMAGING CENTER. THEY TOLD ME I HAVE MY YEARLY APPOINTMENT ON 11/26/2021 AND I WOULD BE EXAMINED AT THAT TIME REGARDING MY CONCERNS. I ALSO CALLED MY GYNECOLOGY OFFICE AND COMPLAINED TO THEM OF MY PAIN. I SAW P.A. AT THE OFFICE ON NOVEMBER 2, 2021. I WAS EXAMINED THERE AND I WAS TOLD THE SWOLLEN LYMPH NODE WAS ONLY TEMPORARY. IT REMAINS AND SO DOES THE PAIN! I VISTED IMAGING FOR MY APPOINTMENT. THEY DID AN ULTRASOUND USING THE WAND UNDER MY LEFT ARMPIT. IT WAS PAINFUL. I WAS TOLD EVERYTHING WAS NORMAL/MEANING THEY SAW NO CANCER AND THAT THE LUMP WAS ONLY TEMPORARY! IT'S NOT! I CONTINUE TO HAVE PAIN EVERY DAY! IT'S PAINFUL TO SHOWER. I CAN'T USE DEODORANT. ALMOST TWO YEARS NOW SINCE I'VE BEEN TRAUMATIZED BY THIS OCCURRENCE. I TRUSTED THE SCIENCE, PHARMACIST AND PFIZER!! THERE IS NO TREATMENT AVAILABLE FOR WHAT HAPPENED TO ME! I WANT TO KNOW WHAT PFIZER IS GOING TO DO ABOUT IT?
significantly increased heart rate; do not feel well; anxiety; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12Mar2021 17:00 (Batch/Lot Number: EP6955) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of bnt162b2 on 19Feb2021 17:00 (lot number: EN6200) in the left arm. Medical history included neurofibromatosis type 1. Concomitant medications included magnesium sulfate and unspecified multivitamin, multimineral, protein. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Since 05Apr2021, the patient have had a significantly increased heart rate. Things seemed to be improving but patient still do not feel well. Patient went to the ER, a cardiologist, and her primary doctor. Patient underwent several tests: blood, EKG, echo, and heart monitor. All seemed to show no signs of any problems but patient still do not feel well. Something is wrong. Since they could not find anything wrong, the doctors were saying anxiety. AE resulted in: Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264467 same patient/drug, different event/dose
not feeling good, not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good, not feeling well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling good, not feeling well). At the time of the report, MALAISE (not feeling good, not feeling well) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
She came home from school 11/4/22 and she told me that she didn't feel well. She had a temperature and it continued the whole weekend. She stayed home from school 11/7/22 and school was closed for elections 11/8/22. On 11/8/22, she did not have a temperature for 24 hours so we sent her to school 11/9/22. We received a call from the school nurse that she had a fever again. I picked her up from school and called her pediatrician. They did not have any appointments available so I took her to an urgent care. There was no Covid-19 or flu swab done because of the length of time with her fever. The doctor listened to her lungs and noticed an imbalance. She did not order a chest x-ray, but diagnosed her with pneumonia and prescribed amoxicillin. She stayed home on 11/10/22 because she hadn't been fever free for 24 hours, but she did return to school on 11/11/22. As of today, she is feeling great. No cough, runny nose or lingering symptoms.
Pt phoned emp hlth the last wk of 11/28/01 to report hx of possible adverse reaction post receiving vaccine 10/27/01 - states 20 min post injection had local reaction @ site within 2 hrs had back pain, spine at tailbone pain. Also notes funny taste in mouth. 11/9/01 had SOB & nausea. Tx in ER 11/14/01 for N&V. Admitted to hospital with tachycardia x 2 days 11/17/01, discharged home - has not worked since 11/12/01.
pt recvd vax & devel t102, fever w/rash no itching; in evening rash itching; skin tingles,edematous face & hands, t100 orally-aching joints; seen by MD 15APR94 MD stated allergy but didn't know to what;
Broke out in a full body rash; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; This is a spontaneous report from a contactable consumer reported (reporter's son). A 12-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 08Jun2021 09:00 (Batch/Lot number was not reported) as dose 2, single (at age of 12-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. No known allergies. Concomitant medications included ascorbic acid (VITAMIN C); vitamin d nos (VITAMIN D). Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18May2021 09:00 administered in left arm (at age of 12-years-old) for COVID-19 immunisation. The patient broke out in a full body rash starting 2 days after the 2nd shot on 10Jun2021. Started on top of his feet and spots on his leg and by the 3rd day, was covering most of his body up to his neck. Red, warm to touch, itchy, it was not too raised, just slightly swollen on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Used Zyrtec and Benadryl per advise of doctor. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No Hospitalization Prolonged. Outcome of the events was recovered/resolved.  Information on the lot/batch number has been requested.
6FEB92 presented w/fluctuant area 1 cm in diameter on lateral aspect of deltoid; somewhat hemorrhagic; area anesthetized w/2% lido; Seen in ER for abscessed arms 14FEB92; 17FEB92 Seen in ER for f/u pain; had muscle spasms, swelling, tingle;
1 of 4 pt who exp severe local rxn (arm red & very swollen);
Within 24 hrs she experienced swelling, redness, soreness, itching in arm where injection was given, but not at injection site (Right arm). Took 25 mg BENADRYL on Tuesday night. Not much better. Did not see her doctor. Still has symptoms as of 12-7-16. 12-8-16 - Patient states it is "getting better".
Vaccine 1 - all arm pain for 6 days Vaccine 2 - severe all body pain for 20 hours, fever, headache caused blindness in one eye, dizzy, weak, ringing in ears.  48 hours after vaccine - pain and fever gone but dizziness and ear ringing still ongoing.
Sore arm; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer (Patient). This consumer or other non hcp reported information for both mother and fetus/baby.  This is a {enter maternal or fetus/baby} report.  A 35-years-old female Pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number EN6208), via an unspecified route of administration on 22Mar2021 at 14:30 (at the age of 35-years-old) into left arm as a single dose for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing Gestation period: 18 weeks. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had allergies to food, or other products. On 22Mar2021 at 14:30, The patient was Pregnant at the time of vaccination. On 22Mar2021 at 15:30, the patient experienced sore arm. The mother was 18 Weeks pregnant at the onset of the event.  The mother was due to deliver on 23Aug2021. No treatment medication was given for sore arm. The outcome of the event was recovering for sore arm and unknown for another event.
The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022; Temp Excursion  Yes; No adverse event; Erroneously vaccinated clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03Oct2022, BUD was reported as 02Nov2022 and was administered on 11Nov2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp Excursion  Yes).    No concomitant medication was reported.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-514142 (Patient Link).
Severe headache and neck pain for two weeks.  Tired and body ache  Shingles on third week
Pfizer-BioNTech COVID-19  Vaccine EUA Metallic taste immediately following injection lasting 2 days 27 weeks 4 days gestation
Pt wanted to report facial swelling possibly due to coronavirus vaccines. Pt noted the day before she got her CV19 vaccines she was having discomfort in her tooth (a molar on the left side).  Pt notes after she got the vaccine she had Left sided facial swelling of sinus/cheeks/neck- denies and swelling throat/mouth. Went to the dentist who took xrays and prescribed penicillin, informed pt facial swelling is most likely the result of the vaccine.
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)   A blister below his breast; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. A blister below his breast has erupted on Jan2021 with outcome of unknown.   Information about batch/lot number has been requested.
Developed rash on both cheeks and around eyes. Hot and itchy. No hives, no difficulty breathing, no fever. States she feels fine. Referred to family physician. Appointment was made by parent, but cancelled because rash had subsided within a few hours after being reported.
This spontaneous report as received from a nurse via company representative, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 21-JAN-2019, the patient inadvertently received an expired dose of PNEUMOVAX 23 lot # N011305, expiration date 20-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). The patient did not experienced any adverse effects.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6198), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FE5430), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hard blood pressure" (unspecified if ongoing), notes: successfully treated; "elevated cholesterol levels" (unspecified if ongoing), notes: successfully treated; "Two cardiac stents placed in 2007 with no issues since then.", start date: 2007 (unspecified if ongoing), notes: Two cardiac stents placed in 2007 with no issues since then. Concomitant medication(s) included: ATORVASTATIN; CANDESARTAN; METOPROLOL; GABAPENTIN; DULOXETINE; VITAMIN D 3. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of covid-19. Clinical course: After his main symptoms (extensive coughing and some nasal congestion) seemed to diminish considerably, they returned, especially the congestion. Paxlovid for Covid-19 treatment started on 29Apr2022 and stopped on 04May2022.  No follow-up attempts are possible. No further information is expected.
Visible rash on left arm forearm, appeared approx. 1 week after second injection.   Not relieved with OTC Zyrtec or Benadryl cream
Redness, itching and swelling at injection site, common cold symptoms, fever ranging between 99 to 101 degrees
Information has been received from a licensed nurse practitioner referring to an unspecified number of patients of unknown age and gender. The primary reporter stated that 90 improperly stored doses of ROTATEQ (lot number# K024700, expiration date 30-JUL-2016, dose, route not provided) were given to an unspecified number of unspecified patients after July of 2014. No adverse effects were reported. Additional information has been requested.
Mucous in throat Cough Runny nose Headache Fever 101.8 No energy, weak Loss of taste and smell
1 of 6 elderly pts who devel inject site rxn following flu vax of swelling & erythema. Pt has had flu vax each yr for the past few yr.
4 hours after headache started. 10 hours severe headache/migraine. 14 hours after vomiting, fever, chills, weakness, body aches. 24 hours after headache, fever, chills, weakness continued. 48 hours after headache continued, noticed slight chest pain. 50 hours after chest pain worsened. 54 hours after chest pain seemed to go away. One week after and still have chest pain on and off throughout the day.
Swollen legs/ankles, achy body, frontal headache/migraine, red welts on legs both sides front and back, itchy and soreness, and bruising.
Information has been received from a registered nurse concerning a female patient in her 40's who was vaccinated with Recombivax HB (Lot # 655871/0570U) 10mcg IM on 05-SEP-2007.  There was no concomitant medication or pertinent medical history.  Within a few days or a week of the vaccination, the patient developed soreness and aches and pain with range of motion of the injected arm.  The patient sought medical attention at the physician's office and was treated with ibuprofen.  The nurse reported that the patient was improving, but the symptoms continued.  Additional information has been requested.
I stay ice cold internally, recently sitting in a vax reporting committee, I watched my hand of my vax arm go pale and get VERY cold and that NEVER happened before my shot. I routinely have brain fog, stood in the elevator leaving after committee for about 5 minutes before I realized I hadn't pushed the button. I ordered grab bars for my bathroom that I didn't need before the shot b/c keeping my balance is a lottery from day to day and my bathtub/toilet is already wheelchair equipped with bars in/around both. I'm shocked I can still walk unassisted but I push myself. I have fatigue like it's a sport. At times, holding a Lysol can requires both arms instead of just my strong arm which I took the shot in. I also have cardiac and other things I had no issues with before August 2, 2021.
After few hours shakes and chills. Then additionally a  major headache that lasted 12 hours.
Patient had previously received 1st dose of Moderna on 5/21/21.  However, on day of clinic 12/1/21, Janseen was given in error in an attempt to complete series.  Patients are monitored per protocol on all patients who received vaccination with none noted.  Vaccinator has been counseled on guidelines that booster can be mixed/matched from original series but primary series cannot.  Doctor notified and understands the error but does not see the need to schedule a follow up Moderna to complete series.  If patient is still admitted in 2 months, we will discuss the potential of a booster with patient/md.
A 9 year old male experienced fever, flu-like symptoms, headache, stomach ache, and leg pain following vaccination with RabAvert for post exposure prophylaxis. The pt was exposed to a bat which was tested positive for rabies, received RabAvert and human rabies immune globulin. After the first dose of RabAvert, he developed fever and flu-like symptoms. There were no adverse events after the second dose. After the third dose, the pt experienced headache, stomach ache and one of his legs was hurt. Follow up information is pending.
Patient complained of dizziness and faint. He then fainted and nurses approached patient as he lied down on the floor to take vitals. Patient experienced what look like a vasovagal reaction. Patient?s mother stated he usually becomes faint after vaccines and blood draw. She explained a recent event about three weeks ago where he fainted during blood draw.  Patient rested and was able to get up after 30 minutes of being monitored. Blood pressures at initial was 135/75 with HR 70. Blood pressure after was 109/70 with HR of 63.
Polyarthralgia and pericardial effusion.  10/17/2007 MR received for DOS 9/16-20/2007 for D/C DX Pericardial Effusion.  Pt presented  with several day hx of joint pain and shortness of breath associated with burning in her throat, also coughing and weakness.  Temp 100.4'F upon eval. PE (+) for JVD Pt had an US guided pericardiocentesis with drain placement.  Drain removed once drainage was <5cc.
Extreme  fatigue, severe body stiffness, pain with movement by over 45 days.  MRI with tendinitis in all tendons within the area examined.  Muscle pains , tendon swelling and pain.     This started to subside after 45 days post-vaccination of the second vaccination.
I started experiencing thousands of PVC a day (premature ventricular contractions)  after the first shot, and symptoms worsened with the second shot.  Holter Monitor reported 2,000 PVCs in 24h. I can feel every single one of those PVCs.  Even at day May 25th,  symptoms are not gone and I still experience hundreds of PVCs a day. I am not sure if this could be due to the potential heart inflammation cases. I don't have stress in my life currently and I have never experience heart palpitations in my life. blood tests to check for electrolytes and other potential trigers of PVCs have come all within reasonable levels.
Experienced non-serious but severe side effect (pain).  Unusual fatigue 7 hrs after injection. Awakened at about 10:30 p.m. (12 hrs after injection) with extreme pain at/around injection site. Very extreme pain. Had me yelling ow!ow!ow! Pain seemed to become generalized across shoulders and to right arm. Most acute phase lasted about 30 minutes. Fatigue and pain gone by next morning. All seemed normal. But every night since (including last night, 2/6/21), in the middle of the night, I have again been awakened by serious (but not nearly as extreme) pain at/around the injection site. Always gone by morning, although slight ache remains.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #: L019299, expiration date: 15-APR-2017 and lot #: 027733, expiration date: 13-SEP-2017 (dose and route were not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.