chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt says, when she got the shot, she got "a small piercing pain in the top of my had that lasted a second. Then I developed the aches and the pains. Around 5:00, I got a little nauseated. Around 7:30 I got up off the couch to go to the bathroom and I was dizzy. Then I went to bed and woke at 3 am and I felt like I was leaning sideways. I was very dizzy". Pt says she's been very dizzy until 7:30 this morning and now she's just a little bit dizzy. "It's like a pressure in my head pushing down and then kind of swimming. It's not continual, it just comes and goes. The nausea is gone".
Pain at injection site, which turned into swelling, redness, and hardness that wrapped around my entire arm from my shoulder to just past my elbow. First urgent care doctor told me that it was Cellulitis and prescribed antibiotic (cephalexin), while it continued to spread and be painful. The next day at urgent care, doctor told me it was inflammatory response. Redness and swelling continued to expand for about a week, then became itchy. I'm 10 days out and can see some redness still near where I got my shot, but the swelling has gone down and things seem to be back to normal.
After vaccination patient reports feeling dizzy, and she is given a alcohol pad, and paramedic proceeds to evaluate, he takes her to the ambulance and takes her Vitals, Sat 99, P82, R23, BP100/55, T36.5. Oxygen was given and kept her in observation, patient reports feeling better and mother signed papers for the minor.
Itching; tongue had become swelled; swelling started in face; throat itching and pain; throat itching and pain; rash/had become worst day by day by rash spreading a whole body/again the rash started coming on face, hand, leg, knees; realized it is adverse impact and acutely allergies/allergies continued to speak whole body including head; This is a spontaneous report from a contactable consumer (patient) via . This 42-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19, had no allergies, and had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included phyllanthus emblica, terminalia bellirica, terminalia chebula (TRIPHALA) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S), both from unknown dates for unknown indications. The patient reported events started 06Apr2021 at 12:00. The patient reported that kind of rash started from second day from the vaccination time. It had become worst day by day by rash spreading throughout the whole body, and on 08Apr2021 throat itching and pain started. The patient visited her primary physician and she realized it was adverse impact and acutely allergies. She prescribed a steroid, "be ADDA do" esomeprazole (NEXIUM) and a course of the steroid for 8 days. The issue was not resolved, and the allergies continued to spread whole body including head. On 12Apr2021 the tongue had become swollen, and swelling started in face. The patient went to doctor again, she checked and suggested to go to an allergy specialist and emergency room if there was no progress. On 15Apr2021 the patient went to emergency room as the itching, pain and allergy had become un-manageable. The doctor treated the patient with a steroid and other medicines intravenously (IV) and she was there for 7 hours. After the IV it felt good, itching reduced and she got discharged back to home. On 17Apr2021, again the rash started coming on face, hand, leg, knees and itching also started. The clinical outcome of itching was unknown; the outcomes of the other events were not recovered. Since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
17 year old male patient received Moderna COVID vaccine. Error was discovered a month later. Patient didn't receive 2nd dose per records
EMPTY SYRINGE INJECTED; SORE ARM; This spontaneous report received from a consumer concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180522, and expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced sore arm. On an unspecified date, the subject experienced empty syringe injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 07-APR-2021, and the outcome of empty syringe injected was not reported. This report was non-serious.
Throat tightness; This is a spontaneous report from a contactable healthcare professional. A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH; lot number: EN6205) via an unspecified route administration and anatomical site on 15Mar2021 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 15Mar2021 (15 minutes post vaccination), the patient experienced throat tightness during waiting period. The patient denied any symptoms of rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient was noted with clear oropharynx and was speaking full sentences with no throat clearing. The patient was treated with water that showed excellent results hence was discharged and stable to go home. The patient was advised to follow-up with primary care physician (PCP). At the time of reporting, the outcome of the event throat tightness was recovering.   Amendment: This follow-up report is being submitted to amend previously reported information: Added patient first name, patient age, vaccination facility country, treatment received captured as yes, concomitant therapy updated as blank and removed duplicate suspect product indication.  No follow-up attempts are needed. No further information is expected.
About five minutes after receiving his first dose of covid-19 pfizer, patient was sitting down in waiting chair and per his mother, as a witness( as I, the pharmacist, was in the vaccine room giving another vaccine to a patient) said he went stiff and fell to the ground and hit his head on the hard concrete then shortly came to it. He didnt remember it but once he came back he said he felt fine and was just shaking a bit. He later said his neck hurt him a little bit. The paramedics cleared him to leave and just told him and his mother to keep an eye on his symptoms, to get rest and hydration.
Headache, nausea, stomachache, fever, sweats, body soreness beginning approx. 8 hours after the vaccine and lasting about 30 hours. Symptoms peaked at about 24 hours after the vaccine. Took acetaminophen and alternated drinking water and Gatorade during worst of symptoms
Information has been received from a physician concerning a 6 yr old female who on 23Nov99 was vaccinated with a dose of varicella virus vaccine live. On 13May05, the pt presented with a case of breakthrough varicella with less than 50 lesions and no fever. Unspecified medical attention was sought. The pt recovered on her own and no treatment was needed. A product quality complaint was not involved. Additional information has been requested.
03/13/2021: Presented to the emergency department for fever, generalized weakness, nausea, and vomiting. The patient was admitted for GI evaluation who stated that the nausea, vomiting, and chronic diarrhea, could be from gastroparesis and diabetic diarrhea versus IBS. The patient was discharged the next day with outpatient follow up with her primary gastroenterologist.
About 10 hours after the vaccine I started to have upper body pain especially above the elbow in my right arm but also on the right side of my neck.  I looked at my arm at 10 a.m. in the morning the next day and saw a large red spot, about 3 inches in diameter, in a circle shape that itched, was warm to the touch, feels hard, and hurts in response to pressure.  It is about 1" below the injection location.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. A male patient of an unspecified age (62 unit unknown) and ethnicity received PREVNAR 13 on an unspecified date at single dose for immunisation. Medical history included heart disease, atrial fibrillation (Afib). Concomitant medication included apixaban (ELIQUIS), amisodarone (AMIODARONE). The patient experienced diffuse maculopapular pruritic rash upper and lower extremities and anterior/posterior thorax on an unspecified date with outcome of unknown.   No follow up attempts are possible. No further information is expected.
FLU VACCINE RECEIVED AT PLACE OF EMPLOYMENT.  ACTUAL INJECTION WS NON-EVENTFUL HOWEVER, THE ADMINSTRATION OF THE VACCINATION MEDICATION WAS QUITE PAINFUL.  APPROXIMATELY TWO (2) HOURS AFTER INJECTION ARM STARTED BECOMING QUITE SORE.  HAVING RECEIVED FLU VACCINATIONS YEARLY FOR MANY YEARS, IT WAS NOT UNUSUAL TO EXPERIENCE SOME TENDERNESS IN THE HOURS AFTER THE INJECTION. THAT EVENING, I EXPERIENCED EXTREME PAIN IN THE ARM AND WAS BARELY ABLE TO MOVE IT.  THIS CONTINUED THROUGHOUT THE NIGHT KEEPING ME AWAKE MOST OF THE NIGHT.  AFTER A FEW DAYS IT DAYS IT WAS FEELING BETTER.  A LITTLE SORE BUT NOTHING SEVERE SO I ASSUMED MY ARM WAS RECOVERING.  HOWEVER, JUST AS I THOUGHT IT WAS IMPROVING, THE PAIN AGAIN BECAME QUITE SEVERE (THIS OCCURRED APPROX SEVEN (7) DAYS AFTER THE INJECTION.  OVER THE FOLLOWING WEEKS, THE LEVEL OF PAIN FLUCTUATED BETWEEN MILD (TOLERABLE) AND SEVERE (MOVEMENT CAUSED ME TO GASP).  ON DECEMBER 14, 2005, I VISITED MY PRIMARY CARE PHYSICIAN.  HE TOLD ME HE FELT THAT THE SYMPTOMS WERE NOT CAUSED BY NEEDLE, BUT DIAGNOSED IT AS A NEURITIS CAUSED BY THE VACCINE.  HE PRESCRIBED NEUROTININ (GABAPENTIN 300 MG TWICE DAILY FOR TWO WEEKS).  I WAS UNABLE TO CONTINUE WITH THAT TREATMENT BECAUSE IT CAUSED SEVERE DIARRHEA AND GAS.  I HAVE AN APPOINTMENT SCHEDULED WITH AN ORTHOPAEDIC SPECIALIST FOR DECEMBER 30, 2005.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M023383 with expiration date 11-MAY-2018; dose and route were unknown). The vaccines were exposed to temperature excursion of 40 degrees Fahrenheit for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 15:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR REDIHALER oral, start date: Jun2015 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive; (21Feb2023) negative; (22Feb2023) negative; (23Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Pt was  given this Imm after the age limit. Pt's mother asked for that Imm and the provider ordered it.  No adverse reaction happened, Imm was given after age limit.
I was unable to urinate and required the insertion of a catheter.  I ultimately had to be operated on to open my urethra.  This is due to my prostate completely blocking my urethra.
Inability to use right leg; Loss of muscle mass; Spasms; Back pain; High fevers; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Inability to use right leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product OFATUMUMAB (KESIMPTA) for an unknown indication.    No Medical History information was provided.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and OFATUMUMAB (KESIMPTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MONOPLEGIA (Inability to use right leg) (seriousness criterion medically significant), MUSCLE ATROPHY (Loss of muscle mass), MUSCLE SPASMS (Spasms), BACK PAIN (Back pain), PYREXIA (High fevers) and CHILLS (Shivering). At the time of the report, MONOPLEGIA (Inability to use right leg), MUSCLE ATROPHY (Loss of muscle mass), MUSCLE SPASMS (Spasms), BACK PAIN (Back pain), PYREXIA (High fevers) and CHILLS (Shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown.  Patient had seen chiropractor and that helped to some extent.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
dizziness; arm pain; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient experienced dizziness and arm pain about 6-8 hrs after receiving COVID-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Janssen-COVID-19-EUA CAMVU-Run #2021005119  25 y/o male with a chief complaint of Dizziness/Weakness post vaccination. Symptoms subsided several minutes after onset. Onscene medic performed full assessment. Pt refused transport for futher eval, pt signed AMA.
woke up with pain; fever; joint pain; muscle pain; fatigue; chills; very cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (very cold), PAIN (woke up with pain), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and (910) 938-9954) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibroma (Last 20 years) and Disability.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FEELING COLD (very cold) and CHILLS (chills). On 02-Apr-2021, the patient experienced PYREXIA (fever), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and FATIGUE (fatigue). On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (woke up with pain). On 04-Jan-2021, CHILLS (chills) had resolved. On 04-Apr-2021, FEELING COLD (very cold), PAIN (woke up with pain), PYREXIA (fever), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and FATIGUE (fatigue) had resolved.            Concomitant medications included pain pills, muscle relaxer, and high blood pressure medication.  Patient did not take any medication to treat symptoms.
June 4 8pm headache, I went to nap  June 5 4am chills and fever, I took tylenol June 5 2pm high fever 103-106F, I took tylenol June 5 muscle aches and loss of appetite
Patient was given Pfizer bivalent without having first recieved the Monovalent series. Patient was 11 weeks, 6 day pregnant at the time of vaccine. No pregnancy complications noted. Error was identified when it was time for patient to receive second dose. Provider and patient were both notified of vaccine error. Patient is scheduled to follow up with provider to discuss future vaccination schedule for Covid-19.
Patient came in 1 day after vaccine administered arm was red, warm, and swollen. Patient then went to ER and was given prescriptions for KEFLEX, BENADRYL, and ZANTAC. MD told her it was either an infection or allergic Rxn.
Started with headache and fever, progressed to chills at 7:00 PM 11/08/2016. 11/09/2016 fever continued, chills diminished overnight, treated symptoms with ADVIL and TYLENOL. Lower back pain and pain in thighs set in during the day 11/09/2016. Fever and headache continued. In the afternoon, dizziness set in for a few hours. Overnight 11/09/2016 back pain became severe, couldn't sleep because of it. 11/10/2016 fever seems to be gone, took 1000mg ADVIL for back pain, headache continues. Symptoms are continuing still.
No reaction from first shot.  Second shot was at 10_00 am on March 16.  On or about March 14 I noticed vision loss in left eye, a spot. On March 17 I made an appointment to be seen on March 23 by optometrist.  Was seen and he identified an inflamed optic nerve d rate tests.  That night or by the following morning I had lost more vision, in a halo around the first blind spot.   Doctors are still trying to determine origin of problem, not tumor and not disease.
Not adverse. Arm pain the following day lasted approximately 2 days, no visible issues at injection site.
She had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm) in a female patient of an unknown age 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 PAIN IN EXTREMITY (She had a sore arm). At the time of the report, PAIN IN EXTREMITY (She had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-402946, MOD-2021-402949 (Patient Link).
EXTREME nausea  like I have never had in my life.  Lasted non-stop for three days.  Unable to eat or drink anything. . Never had a case of food poisoning that was even close to what  I experienced.  I would not recommend it to anyone I know...Like the saying goes I would not wish . it on my worst enemy.  It has turned me into an anti-vaxer.
High Fever 105....chills, lymph nodes in left armpit swelled up...cramps throughout body...arches of feet to neck.  The injection site was swollen for over a week and red (like a sunburn)...hot to the touch.
Got severe dizziness to the point of falling down & not being able to walk, vomiting, and severe headache
I experienced and noticed swelling to my left side between my collar bone of my neck. I felt a lump upon palpation o my sub clavicular lymph node, left side of my neck. They told me to let it run my course and I have a follow up appointment in 6 weeks to monitor the lymph node.   I still have a little lump, lymph node is smaller in size.
Patient presented to ED on 8/17/22 with NSTEMI after receiving one dose of Jynneos vaccine (administered on 8/14/22). The symptoms included chest tightness/heaviness which radiated to his jaw, lasted for about three hours, and resolved prior to ER admission.
Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At  injection site
Patient received Fluad in left arm on 9/22/23. Pt reported to pharmacy on 10/5/23 complaining that her arm still hurt and she had some radiating pain going up her neck. She showed me her arm and she still has a bruise on her deltoid where she got the shot. Patient claims she still has to take Tylenol and is worried about potential nerve damage. She said the pain has not gotten worse, but she can feel it still there and it has not gone away yet.
Breast cancer; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that the patient got breast cancer because of the vaccine on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed a rash in trunk, legs and arms, after his vaccines.  MMR reaction?
No AE, rather an error in administration.  Dose was approximately 30 minutes expired at the time of administration.
Patient indicated on her electronic consent form that her dose on 3/31/21 was her first dose. She was vaccinated without incident with 1 dose of Moderna. Patient returned for her 2nd dose on 4/28/21 and indicated on her electronic consent form that it would be her 2nd dose. However, she disclosed verbally to the pharmacist just prior to administration that it would actually be her 3rd dose. Patient disclosed she had received 1 dose of Pfizer back on 1/22/21. Patient stated that she had consulted with another pharmacist and that person had told her that since her first dose of Pfizer was so long ago, that she should restart her series. The immunizing pharmacist declined to administer the dose on 4/28/21 since it would have been a 3rd dose for her.