chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HPV vaccine administered to left arm while patient sitting on exam table. Patient immediately leaned forward and was unresponsive. Patient was assisted to supine position. Involuntary movement noted of bilateral arms & legs. Lasting a few seconds. MD called for with prompt response and patient responsive at this time.
ring in ears/ ringing worse in left ear; interrupts my sleep; some redness left ear; interrupts daily life; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ring in ears/ ringing worse in left ear), SLEEP DISORDER (interrupts my sleep), EAR CANAL ERYTHEMA (some redness left ear) and FEELING ABNORMAL (interrupts daily life) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure, COLECALCIFEROL (D3) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced TINNITUS (ring in ears/ ringing worse in left ear), SLEEP DISORDER (interrupts my sleep), EAR CANAL ERYTHEMA (some redness left ear) and FEELING ABNORMAL (interrupts daily life). The patient was treated with ASCORBIC ACID, CALCIUM CARBONATE, COLECALCIFEROL, COLLAGEN, GLUCOSAMINE SULFATE, SOYA ISOFLAVONES (HCP) at an unspecified dose and frequency; PREDNISONE at a dose of 20 mg and ENT [CETYLPYRIDINIUM CHLORIDE;EPHEDRINE HYDROCHLORIDE;EUCALYPTUS GLOBULUS OIL;LIDOCAINE HYDROCHLORIDE;MENTHOL;TYROTHRICIN] at a dose of 50 mg. At the time of the report, TINNITUS (ring in ears/ ringing worse in left ear), SLEEP DISORDER (interrupts my sleep), EAR CANAL ERYTHEMA (some redness left ear) and FEELING ABNORMAL (interrupts daily life) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient given flu vaccine around 933 am 10/19/11 around 0940 she passed out in exam room with MD present. Patient wasn't feeling well yesterday and was complaining of dizziness that morning. VSS. A & O x 3. Laid down, legs elevated, assisted to chair after while, given H2O & candy.
Severe fatigue could not get out of bed, massive shortness of breath, massive hives all over body. Similiar to large reactions I get when I accidently eat nuts. I did not eat any nuts or had the chance that any of my food had nuts in it.  I had to use 200 mg of Benadryl and my 2 Epipens to get myself back to normal. I did not go to ER, but almost did. I hate going to ER, takes too long and they give you so many steroids and meds when you have bad reactions that I did not want to go again. I would have gone if the symptoms did not get better with my Benadryl and Epi Pen.
Patient developed right lower extremity DVT (unprovoked) diagnosed on 3/26/21.
On 12/21/2022, the patient presented for a 2 months well-child visit. However, the patient was a few days early for this visit.  Because of this early scheduling, our system, and DH system, both failed to show some of the patient's needed 2 months vaccines.  As a result, the patient was only given the Hepatitis B vaccine on 12/21/2022.  The patient did not receive the Rotavirus vaccine on 12/21/2022 because the patient's office visit was scheduled at least three days too early for the Rotovirus administration.   The Hepatitis B vaccine given on the 4 months well child visit on 02/27/2023.   Rotovirus vaccine was not given- there is no adverse event. There is a error in the alert system.
After 1st covid shot, checking fasting blood sugar in mornings, noticed readings were much lower than usual. started lowering insulin shot in evenings to compare. Readings in mid 60's. After 2nd shot in August, couple days later, sugar bottomed out at 35 according to ambulance paramedics. went to e.r. and back home couple hours later when stable. Event happened once more 1 week later and ended up in e.r. again for couple hours. just seemed odd events occurred right after 1st and  2nd covid shot.
3/1/2023 in the morning I had a headache, and fatigue. I tested with an at home COVID-19 test, positive. Symptoms got more pronounced, developed a fever peaking at 101.8, and a cough. Symptoms were not severe. 3/3 Televisit with doctor who prescribed PAXLOVID. 3/6 symptoms started improving over the course of the day. Symptoms continued for about a week more. Mild cough and fatigue lingered for about 2 weeks more.
PATIENT CAME TO GET A MODERNA BOOSTER (0.25 ML) DOSE, BUT RECEIVED A FULL DOSE OF MODERNA INSTEAD (0.5ML)
No adverse reaction.  Patient was given J&J at dialysis after receiving Moderna at the health department about one month ago.
Left arm (deltoid area) swollen, red, and painful at injection site.  Recieved vaccine on 12/11/08, symptoms started 12/12/08. Diagnosed with cellulitis/abscess (probably sterile) of left arm. Course of treatment - cool compress BID for 3 days for 20 minutes each, Prednisone 20 mg 1 by mouth BID for 3 days, if abscess not better in three days then to begin Cephalelin 500mg, 1 by mouth TID for 7 days.
Pfizer COVID-19 Vaccine EUA  Patient received Dose 1 of Pfizer vaccination 3/8/2021.  Patient presented to ED 3/23/21. The patient presents cough and SOB for 2 weeks, now with orthopnea and chils. Has A fib on Eliquis, HTN, s/p pacemaker for heart block. Did not smoke but got exposed to lots of dust growing up. The onset was 2 weeks ago. Denies chest pain, denies nausea, denies vomiting, denies abdominal pain, denies back pain, denies weight gain and denies hemoptysis.  3/25/21: The patient was admitted to the medical floor and placed on ceftriaxone 1 g IV piggyback daily and doxycycline 100 mg PO BID. Additionally he was placed on Decadron routinely. He is significantly improved over the past 2 days. His IV did infiltrate last evening and ceftriaxone was discontinued and he was started on cefdinir 300 mg PO BID. He has done well since being in the hospital. He did run 1 fever about 24 hours ago but since then has felt fine and has been afebrile.  His cough has significantly improved although he still continues to demonstrate an occasional dry cough.  At this time he is felt to be stable enough to go home. He is no longer requiring supplemental O2. He has had no further hypoxia.
Had eruptions of welts on left upper chest with slight blistering Sight on Rt inner lower leg started on Saturday from a mild blister to a welt the size of your fist that was red and purple bruised with a large blister
Numbness, parasthesia in extremities starting in feet, working way up legs to upper body, hands fingers.  Complete loss of function in left leg resulting in 2 falls, but regained ability to walk.  Blurred distance vision left eye, double vision that resolved, chest pain, intermittent panic attacks with SOB- no prior history.
Three hours post vaccine, onset of moderate headache, moderate body aches, moderate fatigue. Twelve hours post vaccine, onset of severe headache/body aches/fatigue/chills/night sweats. Treatment: 1000 mg acetaminophen every 6 hrs
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. Nurse reported that the patient was administered a second dose of PROQUAD (lot # reported a H015601, 0.5 ml, subcutaneous) after the labeled expiration date(reported as 06-JAN-2014) that had been properly stored on 19-FEB-2014. No adverse events were reported. The outcome was unknown. This was one of the three reports that received from the same reporter (linked with MARRS#1407USA003926 and MARRS#1407USA004510). Lot H015601 is not a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested.
Developed lymphadenopathy in left axilla that then developed into lymphedema in left arm. Also had weakness and pain in left arm. After 1 day also had lymphadenopathy and lymphedema in right arm. Had associated pain in bilateral hands, wrists, and forearms. Symptoms gradually resolved over 2 week time span.
WOKE AT 0700 DAY AFTER ANTHRAX INJ. WITH EDEMA/ERYTHEMIA AT INJECTION SITE.  THE EDEMA SPREAD TOWARDS ELBOW& TOWARDS NECK DURING DAY AFTER. PT HAS PAIN UP AND DOWN ARM. PT LOSING SLEEP AND HAS DIFFICULTY MOVING HIS ARM UP TO THIS POINT (48 HOURS AFTER INJECTION.) PT SAID HE HAD VERY SIMILAR SIDE EFFECTS DURING LAST ANTHRAX IMMUNIZATION IN MAY 2009.
This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age (Age: 17; Unit: Unspecified) received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash under both eyes and abdomen. The outcome of the event was unknown. Information on the lot number has been requested.
Tingling on left side of face 30 min  after vaccine.; Tired; back pain; stomach pain; Swollen lymph nodes in neck, chest and under arm; Swollen lymph nodes in neck, chest and under arm; Ct scan at emergency room shows multiple small benign appearing cervical nodes.; Pain, extreme pain in neck from glands; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: En6207, patient was 51-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 03:45 PM as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. No covid prior vaccination, not tested for covid post vaccination. On 26Mar2021 at 16:15, the patient experienced tingling on left side of face 30 min after vaccine, on 26Mar2021, the patient experienced tired, back pain, stomach pain, swollen lymph nodes in neck, chest and under arm, swollen lymph nodes in neck, chest and under arm, CT scan at emergency room shows multiple small benign appearing cervical nodes., pain, extreme pain in neck from glands. The patient underwent lab tests and procedures which included CT scan: multiple small benign appearing cervical nodes on 26Mar2021. Patient received treatment for events. AE resulted in to visit doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcomes of events were not recovered.   No follow-up attempts are possible. No further information is expected.
I received my Covid-19 vaccine on 01/13/2022. On the morning of 10/25/2022 I woke up with extreme lethargy, extremely sore and really congested. I reached out to my doctor on 10/27/2022 and was prescribed Paxlovid. Symptoms lasted about two weeks.
Rash on belly 12/7/07. Fever up to 100 F for 12 days after immunizations.  Not sleeping well.
Narrative: Presents approximately 2.5 months after first and second Materna injection of which he had severe rash bilateral arms. Provided referral today with evidence of SEVERE reaction. steroids essentially ineffective parenterally, dermatologist indicating immediate allergic reaction one day after first vaccine and informed "will have to run its course and improve". talking once daily antihistamine and topical steroids. remains mildly pruritic.and now evident as scattered rash bilat forearms.
states that he feels sometimes the nausea, but he doesn't get it every day, gets it once on a while; it made him feel sick, but it wasn't as bad as the first one; the first day was fine but that night he was super cold as ice; had 3 blankets on because he was shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, FEELING COLD, CHILLS, PYREXIA, and NAUSEA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He had Covid19 in January). Concomitant products included ESCITALOPRAM for an unknown indication.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced ILLNESS and PYREXIA. 26-Jul-2021, the patient experienced FEELING COLD and CHILLS. On an unknown date, the patient experienced NAUSEA. At the time of the report, ILLNESS, FEELING COLD, CHILLS, PYREXIA, and NAUSEA outcome was unknown.            No Treatment mediation were reported.   This case was linked to MOD-2021-281448 (Patient Link).
Headache; arthralgia; chills, fever, nausea, malaise, hot flashes, dizzness - Information has been received from a registered nurse concerning a 47 year old female patient with hypertension, gastroesophageal reflux disease and allergies to acetaninophen (-) oxyondone hydrochloride (percocet) and trazadol) hydrochloride (ultram).  It was noted that the patient also has a reported history of varicella however, her titer was shown to be unequivocal.  Additionally, it was noted that the patient was exposed to varicella in the hospital and was consequantly vaccinated in the left deltoid with a first dose of varicella virus vaccine live on 28 Mar 2000 (631169/0711J).  concomitant therapy included fosinopril sodium salt (monopril) norethindrone acetate (Aygestin), omeprarole (prilosec) and hydrochlorothlaride (manufacturer unkown).  On 38 Mar 2000 the patient developed a headache that became serve.  She also experienced dizziness, chills, hot flashes, her temperature increased to 99.4 and aching joints especially in her right knee, left elbow with the greatest pain in her right shoulder.  Additionally, it was noted that the patient experienced nauses and malaise.  Follow up information from a registered nurse reported that on an unspecified date the patient recovered.
On set of a rash erythematous follicular dermatitis pruritic extending down auxiliary line from both auxillar and spreading ant. and post around trunk. Caudally almost to the waist, arm and  cys lateral almost to the shoulders and around upper arms. Medrol dose pak, and BENADRYL.
arm hurt; difficulty sleeping on side; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and difficulty sleeping. On an unknown date, the outcome of the pain in arm and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the pain in arm and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on her left arm. After receiving Shingrix, the patient's arm hurt for a week or two weeks and she could not sleep on her side. The reporter consented to follow up. This case was linked with case US2020AMR081357, reported by the same reporter for the same patient. This was 1 of 4 linked cases reported by the same reporter.
Subjective: Patient is a 27 y.o. female Chief Complaint: Arm Pain     HPI Pt had 2nd COVID vaccine 6 days ago, had some soreness of the arm after the first vaccine but almost immediately after this vaccine, pt had pain in the L arm that was significant.  Has seemed to increase since then, hurts to move the arm, holding it close to her with elbow flexed seems to be the least painful.  Has tried ice and heat, ibuprofen and acetaminophen without significant relief.  Pt is breast feeding 8 mo old daughter, having a hard time picking her up and caring for her as most motions with L arm cause significant pain.  Pt is here with husband who agrees that pt has cried with pain, reports at least 7/10.  No swelling or erythema, no fever, not feeling ill, just pain L shoulder.  Pt does state the vaccine was given in the L arm and points to very near shoulder as site of injection. Assessment / Plan: 1. Acute pain of left shoulder - likely SIRVA post COVID vaccination, recommend ice/heat, ibuprofen/acetaminophen for pain, husband to help with passive ROM and demonstrated pendulum exercises, topical options reviewed, PT offered and pt approves.  May wish to use Biofreeze for symptomatic relief.  Discussed possible duration of sxs, will try to decrease the duration with PT, if possible, as pt had 8 month old daughter, pt and husband agree.  To call if new or worsening sxs in the interim.  - PT EVAL AND TREAT; Future
Brief syncopal episode (seconds) with some jerky movements, approximately 4 hours after Td immunization.
Initial report received from a consumer (the patient) on 27 October 2014. The reporter also reported another adverse event on the same day which is captured under the case 2014SA148532 (cluster). A 52-year-old female patient, with no reported medical history and no known allergies, had received a dose of FLUZONE (lot number U2744AA, route and site of administration not reported) on 15 October 2008. She did not receive any previous dose of this vaccine. On the same day of the vaccination, she went home from work, fell asleep; had throat tightness and palpitations. The patient was able to drink water and sat for about an hour and it resolved. There was no relevant diagnostic tests done. The patient outcome was recovered. Documents held by sender: none.
Syncope, persistant chronic insomnia, decreasing after a few weeks, local reaction nodule at injection site.
This spontaneous prospective pregnancy report was received from a nurse and refers to an approximately 33 year old female patient. Concurrent conditions included anaemia. The patient had a previous pregnancy. Concomitant therapies included unspecified prenatal vitamins. Historical drugs were not reported. On 14-MAR-2018, the patient was vaccinated with a dose of VARIVAX Injection, lot # N017394, expiration date 07-JUN-2019, for prophylaxis (strength, dose, dose number, route and anatomical location were not reported). The dose was reconstituted with sterile diluent. The nurse informed that the patient became pregnant, with an estimated Last Menstrual Period (LMP) of 20-APR-2018, and an Estimated Due Date (EDD) of 25-JAN-2019. The patient had an unspecified pregnancy test on an unspecified date in 2018, and the pregnancy was confirmed with an ultrasound performed on 13-JUL-2018. The patient was 12 weeks and 0 days pregnant on that day. No treatment was given to the patient as a consequence of the exposure. At the moment of this report, the pregnancy outcome was pending and the fetal outcome was unknown.
5 unspecified patients experienced syncope/3 of the unspecified patients were male; This spontaneous report was received from a physician via a company representative and refers to 3 male patients, at the age range of 11 to 16 years old. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of vaccination, lot# and expiration date were not provided) for prophylaxis. After administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patients experienced syncope.  The outcome of the event was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as dose not changed. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003881:
Covid Arm: bright red spot at site of injection, 5-6cm, swollen, firm, tight and painful when moving arm, slightly itchy; starting to go away today (6 days after), turning light brownish, no longer painful or swollen. I had this happen once before (4th or 5th Covid vax, can't remember if that was Moderna of Pfizer). Last time it took longer for the spot to appear (5 days?) and it lasted longer (at least 2 weeks). Other symptom: 101º temp day after vaccine, only lasted one day.
Large reaction on left deltoid extending to elbow; 1 day after receiving vaccine. Rx'd with Benadryl.
UTI with dysuria, general bladder and urinary tract pain, bloating, fatigue, brain fog on the worst days. Started shortly after second vaccination. Has not responded to treatment with several different oral antibiotics--or rather, I get better then worse again a few days later. Possible interstitial cystitis. Still receiving testing and treatments.
Patient remained in the monitoring room for an hour after her vaccine. She had no adverse events for the first 15 minutes, but staff found her responsive only to sternal rub, slumped in her chair 1 hour after vaccine.
Lymphadenopathy noted transiently for approximately 48 hours total. Mild tender right axillary node enlargement with no other symptoms or fever. Mild injection site discomfort noted.
Chills, fever, body aches - night of vaccine Muscle twitching in arm of vaccine starting  3/17 Night sweats 3/17
Headache, Myalgia, Arthralgia, chilles, bone ache Narrative:
Received vaccines 09/04/12, states started having trouble breathing 09/05/12. Both arms started turning red at the injection sites. Presented to office 09/06/12 - no respiratory distress, bilateral reddened areas to arms approximately 3 in. across and 5 inches down the arms. Pt. self-medicated with BENADRYL, which she states helped.
Wrong vaccine administered; Ischemic stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 25Oct2022, outcome "unknown", described as "Wrong vaccine administered"; ISCHAEMIC STROKE (hospitalization, disability, medically significant, life threatening) with onset 19Nov2022 at 15:00, outcome "recovering", described as "Ischemic stroke". The patient was hospitalized for ischaemic stroke (hospitalization duration: 4 day(s)). The event "ischemic stroke" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of ischaemic stroke. Clinical Course: The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. AE treatment: Rehabilitation. No covid prior vaccination. Not tested for Covid post vaccination. No known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & w/in 48hrs of inj devel bradycardia (exact heart rate not specified);the bradycardia persisted for an hr & then resolved;
large, raised, red, hot, itchy blotches appeared in area of injection site 5 full days after injection.