chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Significant reaction occurred about 7-10 days or so after I got the vaccination. Glands got very swollen and big (up my entire neck on both sides), glands were extremely large on the left-side all the way my throat & neck and especially behind my left ear, sore throat, felt awful.  Dizziness ensued after the sore throat subsided but glands were still pronounced.  I went to see my regular physician and an ears, nose, throat surgeon in October.  Since that time, I have also seen an inner ear specialist, a neurologist a couple of times; I have taken many tests including an MRI, VNG test, hearing test, etc. etc.  Dizziness and vertigo persists. I am in a constant state of dizziness, disequilibrium and having difficulty walking.  I feel a tremor on the left side of my face and in my left temple on a constant basis.  The nausea is constant, and I am always sick.  I have lost a significant amount of weight.
1 yr old w/ h/o recurrent cough w/ wheeze, who received 1st MMR, VAR & HAV on 6/11/09. Child was healthy that day. Day after woke up w/ face edema -> better. Same next AM + cough & wheeze, SOB. Taken to ER -> SOLUMEDROL, BENADRYL & XOPENEX. Sat 96 -> hospitalized, continued w/ same med. & IVF. Lung w/ wheezes and rhonchi & retractions. Improved, home on 6/14/09.  7/20/09 Hospital records received DOS 6/14/09 to 6/16/09. Assessment: Asthma Exacerbation.  Patient woke up with edema of the face, which improved and then recurred. Patient presents with edema of the eyelids, coughs and wheezes, some difficulty breathing. Pulse of 156 and respiratory rate of 32. Decreased appetite and decreased urinary output. Bilateral wheezes and rhonchi. Intercostal retractions.  7/13/09 ICD-9 Codes 493.92
Headache, Myalgia, Fever, Diarrhea, Extreme fatigue Narrative:
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 78 but did not have frequent medical contact through the system. He had pulmonary fibrosis with severe hypoxemia that required 5 L of oxygen. Other disease states of HLD, HTN, and anemia appeared to be under control per note from 3/25/20.
Fever of 101, body aches, chills, dizziness; Body aches; Chills; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 08Apr2021 at 08:30(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24March2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08April2021 at 17:30, the patient experienced fever of 101, body aches, chills and dizziness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 101, body aches, chills, dizziness were recovering, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received through pregnancy registry from a licensed practical nurse concerning a 16 year old female, with an allergy to AMOXICILLIN, AUGMENTIN and no pertinent medical history, who on 02-OCT-2007 was vaccinated with her first dose of GARDASIL (lot # reported as 656371/0181U).  On 27-DEC-2007, the patient was vaccinated with her second dose of GARDASIL (lot # reported as 656371/0181U).  Concomitant therapy included MENACTRA.  Subsequently, the patient became pregnant.  The patient's last menstrual period was in November 2007.  No symptoms were reported.  The patient sought medical attention.  A home pregnancy test was performed and the patient had an ultrasound on 12-FEB-2008 which reported that the patient was 12 1/7 weeks of pregnancy and with normal findings.  Follow-up information was received from a physician who reported that during the pregnancy, the patient gained low maternal weight (7.4 pound).  On 25-AUG-2008 the patient gave birth to a live  born female weighing 7 lbs.  15 oz APGAR= 7/8.  She was 40 weeks from her last menstrual period.  The infant was reported to be normal and there were no congenital anomalies or other complications.  Additional information is not expected.
Breakthrough case of Covid - sx began on 06/15/2022. Tested positive on 06/16/2022. I woke up with a sore throat with some phlegm and congestion in my chest on 06/15/2022. On 06/16/2022 I woke up with a fever of 101, head ache, body aches, congestion and cough. I took a home test on 06/15/2022 that was negative. I took 2 home antigen tests which came back positive. I went to a mobile testing site and was tested, but I have not yet received the results yet. Today, 06/17/2022, my fever is a little lower of 99-100. I still have congestion and cough and the headache is not as bad. On 05/27/2022, I was sick with the flu for a full week, I had a fever for 5 days.
Patient received 2nd dose 10 days after administration of the 1st dose, not 21 days as recommended. Patient observed 15 minutes after injection- No adverse reaction reported
About 4:30, 6 hours after receiving vaccination I felt nauseated, muscle aches, horrific headache, and weak. By 6:30 I felt like my body was burning up on the inside but had no fever. My muscles in my neck became extremely tight and my ears aches. The injection site is extremely tender and hurts to lift my arm. As of 11 am the next day I have also added diarrhea to the list of symptoms.
Patient Received First Dose a Month and a Half Ago, Was Refused Second Dose; Initial Report Received on 26-May-2023.  A nurse reported that a 19-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not get the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unspecified site.   On 26-May-2023, one and a half months after having been vaccinated with HEPLISAV-B, the patient presented to a pharmacy and was told she could not get the second dose because she "isn't 20 years old."   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
uncontrollable shivering and chills; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 113 years old female patient who experienced shivering (chills), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Dec-2019, the patient received a one dose (0.5 mL) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (frequency once) lot UJ293AA and expiry date 15-Jun-2020 via unknown route in the right deltoid.  On an unknown date, the patient experienced a non-serious shivering (chills) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was chills.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown.
Sore arm; Tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2022-607275 (Patient Link).
Patient was scheduled to receive their 2nd dose of Monovalent Moderna 6mo-5yr but inadvertently received Moderna 6mo-5yr bivalent as their 2nd dose
in order it developed: tiredness, rash on upper arm (initially 1" in diameter and growing to 4" across by the evening of 03/09/2021), chills (evening and overnight), fever (all day 03/09/2021; 99.9F); headache (03/09/2021), soreness under left arm (03/09/2021, abating after a day or two), periodic nausea (03/09/2021-03/11/2021).
Fever higher than 101.5  Widespread arthralgia and myalgia Abdominal pain, nausea Headache
Swelling at joints and painful at each move - left wrist, knees, ankles.  Unable to walk and handle things with left hand.  It started with just one left wrist, and worsened to other joints.  Lasted about one and a half month.
Bell's Palsy symptoms - currently on prednisone 50mg 1qdx7d and valtrex 1gm 1tidx7d
Rec'd MCV4 in (R) deltoid 7-30-13 (2nd dose). 1st dose 6-26-09 - no reaction. C/o 5 1/2 cm round erythematous area with itching on lower deltoid area.
This spontaneous report as received from a healthcare worker refers to an 18 year old non-pregnant female patient. On 27-MAR-1999, 27-MAY-1999, and 02-NOV-1999, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) for prophylaxis. On an unknown date the patient experienced hepatitis b antibody negative. The outcome of hepatitis b antibody negative is unknown. The causality assessment was not provided. Additional information has been requested.
#1: no soreness, no redness in left arm #2: Mild soreness in arm if pressure applied to injection site in evening of day of shot; all gone by morning #3:  Moderate soreness in right arm if pressure applied to injection site; perception of mild swelling in muscle at injection site; soreness gone by morning of subsequent day. moderate inflammation about the size of a 50¢ coin at injection site with roughness on a medium pink inflammation at injection site still observed 7 days later when bandaid first removed.  Smooth medium pink discoloration the size of a 50¢ coin observed 15 days later. Light pink discoloration the size greater than a quarter coin ovserved 19 days later. Slight pink after 23 days quarter sized.
A big red hot swollen lump on arm; A big red hot swollen lump on arm; A big red hot swollen lump on arm; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (A big red hot swollen lump on arm), ERYTHEMA (A big red hot swollen lump on arm), FEELING HOT (A big red hot swollen lump on arm), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination.     No medical history information reported .  Concomitant products included CITALOPRAM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (A big red hot swollen lump on arm), ERYTHEMA (A big red hot swollen lump on arm) and FEELING HOT (A big red hot swollen lump on arm). 31-Mar-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (A big red hot swollen lump on arm), ERYTHEMA (A big red hot swollen lump on arm), FEELING HOT (A big red hot swollen lump on arm), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.            Treatment information was not provided.
within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Hard to walk. progressivly got worse to point unable to walk without pain, lay down without pain. only able to sit.  Steroids, NSAIDS, ICE, Whirlpool Therapy, message, chiropractor. Neurologist consult unable to walk.    2/1/21 MRI completed Circumferential disc bulge with superimposed left lateral recess and foraminal disc protrusion at L4-5 resulting in moderate to severe left foraminal stenosis and impingement of the exiting left L4 nerve root.  There is contact of the traversing bilateral L4 nerve roots with some mass effect on the traversing left L5 nerve root.  Correlate for left L4 and/or L5 radiculopathy.   3. Circumferential disc bulge with superimposed right lateral recess and foraminal disc protrusion at L2-L3 with contact the traversing right L3 nerve root, but no nerve root compression.  No compression of the exiting right L2 nerve root.  Correlate for right L3 radiculopathy   It is my impression that patient presents with acute onset of left L4 radiculopathy.  Her MRI scan suggests a far lateral/foraminal left L4-L5 disk herniation.  She also has some underlying lateral recess stenosis which is fairly mild.     I discussed the above findings with patient and her husband.  I reviewed her MRI scan with the help of a spine model.  I outlined both conservative and surgical approaches.  However, given her findings and the severity of her pain currently, I think one could argue that a left L4-L5 microlumbar diskectomy via far lateral approach would be her most definitive option.  I did outline this procedure in detail with the help of a spine model.  I outlined the risks which include but are not limited to infection, bleeding complications, nerve root and/or cauda equina injury, cerebrospinal fluid leak, recurrent disk herniation, spinal instability, the possibility that she could require additional spine surgery in the future, and the possibility that her would not be relieved to her satisfaction.  We also discussed trying a left L4-L5 foraminal steroid injection but she has had injections in the past and she actually felt like it gave her more pain.  At this point she would like to go ahead and schedule the left L4-L5 microlumbar diskectomy via far lateral approach with METRx.  This will be scheduled on an elective basis in the near future.
I felt a crippling pain along the left side of my spine to my left leg; I was in a lot of pain and felt my left leg was useless until this morning; I was in a lot of pain and felt my left leg was useless until this morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 11:15 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polio" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Seizures" (unspecified if ongoing), notes: History of seizures but no medication currently; "Rheumatic fever" (unspecified if ongoing), notes: 8 yrs of Penicillin for rheumatic fever. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Apr2021 12:30, outcome "recovering", described as "I felt a crippling pain along the left side of my spine to my left leg"; PAIN (non-serious), LIMB DISCOMFORT (non-serious) all with onset 09Apr2021 12:30, outcome "recovering" and all described as "I was in a lot of pain and felt my left leg was useless until this morning". Therapeutic measures were not taken as a result of pain in extremity, pain, limb discomfort.  Additional Information: 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. About an hour after the shot, she felt a crippling pain along the left side of her spine to left leg. Being a polio survivor whose left side was affected, she was in a lot of pain and felt her left leg was useless until this morning. She was worried about the effects the second shot might have on her body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site is warm to the touch, red in color, swollen and very  firm to the touch.
Retractable injectable 1 inch syringe & needle malfunction - vaccines spilled over instead in the muscle. Revaccinated patient with a new dose.
large (6" x 8") raised red area with several smaller areas of rash/lesions, lasting about 10 days
Patient tested + for COVID-19 today, presents with c/o body aches, chest pain, fatigue, nausea, vomiting, and diarrhea. Also discovered to have a pulmonary emboli.
4 days after each dose of series started having vestibular symptoms. First dose resulted in disequilibrium that was positional (up and down movements of the head) at first and the progressed to persistent the next day and ended with a migraine headache that night. Better during the weekend and then took about 2 weeks to resolve. Had almost fully resolved (would still return with ingestion of antihistamine so had to stop taking it) but then got second dose and was initially ok,  but 4 days after dose started having rotator vertigo L sided. Vertigo and disequilibrium were never symptoms of known schwanomma. The schwanomma is small 3mm and intralabyrinthine. Negligible hearing loss at baseline of 25 dB at 4000 Hz. Both ENT physicians acknowledge temporal link but agree hard to tell because vaccine is so new and hard to conclude causation and none of the routine evaluation for the schwanomma fit the clinical picture.
About two weeks after receiving my third dose, I would experience itching in various places of my body. It seems to be in the warmer areas of my body. It reminded me of a liver problem that I experienced eight years ago. When I went to see my doctor, I was given an exam. I had a chest x-ray and blood work completed. Everything seemed to be normal.
contracted COVID-19; contracted COVID-19; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on an unspecified date in Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was at the pharmacy to receive her second dose of the COVID-19 vaccine. She had received her first dose of the vaccine in Mar2021 at a different pharmacy, contracted COVID-19 after (date unspecified), and received antibody therapy for it on 02Apr2021. The clinical outcome of 'contracted COVID-19' after was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
PATIENT RECEIVED PFIZER VACCINE THAT WAS AFTER THE BEYOND USE DATE RECOMMENDATION BY MANUFACTURER.
TWO BIG KNOTS ON SHOULDER; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced injection site soreness. On 02-JUN-2021, the subject experienced two big knots on shoulder. The action taken with covid-19 vaccine  was not applicable. The patient recovered from injection site soreness on 01-JUN-2021, and had not recovered from two big knots on shoulder. This report was non-serious.
an expired dose of MENACTRA was inadvertently administered to a patient. The dose expired on 17APR2022, with no reported AE; Initial information received on 26-Apr-2022 regarding an unsolicited valid non-serious case received from an other health professional via nurse.  This case involves a 17 years old male patient who took an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was inadvertently administered to a patient, the dose expired on 17-Apr-2022, with no reported AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Apr-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection once (total) (lot U6921AB, expiry date: 17-Apr-2022; strength: unknown) via intramuscular route in the right upper arm as Immunization.  On 26-Apr-2022, an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine which was inadvertently administered to the patient and the dose expired on 17-Apr-2022, with no reported AE (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event (expired product administered).  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 the guidelines. 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.
On 10/26/2022 the patient above received a .5 ml dose of Moderna Monovalent instead of the intended dose, Moderna Bivalent .5 ml. The Patient waited in the office lobby for 15 minutes after administration and had no reactions or side effects.