chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; LOST SIGHT IN LEFT EYE; This spontaneous report received from a patient via a company representative via social media concerned a female of an unspecified age. 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 was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had a blood clot and lost sight in the left eye. The patient reported that " Had a blood clot lost sight in my left eye over the J&J shot ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and lost sight in left eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220906147-covid-19 vaccine ad26.cov2.s-Blood Clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220906147- Covid-19 vaccine ad26.cov2.s- Lost sight in left eye . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/09/2021. PATIENT FULLY VACCINATED ON 02/26/2021.
This spontaneous report as received from a nurse refers to an unknown patient of unknown age and gender. On an unspecified date between 16-JUL-2013 and 25-JUL-2013 the patient received an unspecified single dose of improperly stored PEDVAXHIB, injection (lot number H017031, exp. date 16-JAN-2015, route not reported) at an unspecified off site clinic. The reporter stated that PEDVAXHIB had been exposed to total time out of range a maximum of 60.5  hours at minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source (MARRS # 1308USA002370, 1308USA003562, 1306USA003561, 1308USA003560). Additional information has been requested.
shakes and had difficulty finding the right words; shakes and had difficulty finding the right words; This spontaneous report was received from a physician via company representative refers to a 86-year-old male patient. There was no information about the patient's concurrent conditions or concomitant therapies provided. The patient's medical history included stroke. On 19-JUN-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(formulation, dose, route and exact site of administration, lot # and expiration date were not reported) for prophylaxis. On the same day(also reported as one hour after vaccination), the patient experienced shakes and had difficulty finding the right words. He was taken to an unspecified hospital (also reported as hospitalization; went to hospital) however it was unknown by reporter if the patient was admitted to that hospital. In approximately June 2019 (reported as in an unspecified hospital), magnetic resonance imaging was done and it showed an old stroke. It was unknown by reporter if the patient was still at the hospital or if he was currently alive. The outcome of shakes and difficulty finding the right words and relatedness between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) were not reported.
This is a 30 year old male Caucasian who had been in his usual health until 05/29/04. He received his primary smallpox vaccination on 05/21/04 in his left deltoid area. He completed all required briefing and screening prior to vaccination. He also received his second Anthrax on 05/17/2004. Upon waking on 05/29/04 he felt like he had the flu, i.e. fever (subjective), chills, body aches (8/10) and headache (9/10).  He described the headache as feeling like someone was constantly applying pressure. The symptoms did not resolve until 06/01/04.  Later in the evening of 05/29/04, the client noticed "pimple" like eruptions in his hairline and forehead, which was painful to touch. He treated it with tea-tree oil, without relief. These eruptions eventually spread to back, chest, abdomen and upper arms. He was referred to the Vaccine Healthcare Center (VHC) for further evaluation and treatment.
Vaxelis was accidentally administered to an adult patient; The caller states that the physician ordered a Tdap vaccine and the MA administered Vaxelis.; Caller with medical facility called to report that Vaxelis was accidentally administered to an adult patient. Patient was 28 weeks and 1 day pregnant; This non-serious spontaneous safety report, with reference number 2023SA049850/ Inquiry# 01487665 was received by a partner on 10-FEB-2023 and forwarded on 13-FEB-2023 from a non-health professional.   Due to the nature of the event, the causality between the events "Vaxelis was accidentally administered to an adult patient", "the caller states that the physician ordered a Tdap vaccine and the MA administered Vaxelis" and "Caller with medical facility called to report that Vaxelis was accidentally administered to an adult patient. Patient was 28 weeks and 1 day pregnant" and Vaxelis was not applicable.  Further information is expected.
cellulitis; infection; pain seemed to spread to my inner elbow area / It was intense pain; pain seemed to spread to my inner elbow area / It was intense pain; skin became red; skin became red and swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0172), via an unspecified route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), chronic constipation, silent reflux, allergies to several antibiotics and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN), omeprazole, magnesium citrate. The patient previously took doxycycline, clarithromycin (MACROBID), and erythromycin and experienced allergies to all. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 07Apr2021 (at the age of 48-years-old) for COVID-19 immunisation and experienced pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area about 10 days after the first shot (there was nothing visible, just pain). The patient did not receive any other vaccines within 4 weeks of the vaccination. At the time of the second vaccination, the patient still had ongoing pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area, which she experienced 10 days after the first vaccination on 17Apr2021. On 02May2021, after the second vaccination, the pain seemed to spread to the inner elbow area, and it was intense pain. The skin became red and swollen and in that one location. The patient visited the doctor on 03May2021, and he was not sure if it was cellulitis or another type of infection, and prescribed antibiotics, cefdinir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of cellulitis, infection, "pain seemed to spread to my inner elbow area / It was intense pain", skin became red and swollen was not resolved.
5 minutes post vaccine the patient reported heat, redness, and stinging/burning at and around injection site. We administered diphenhydramine 25mg PO stat and provided her with an ice pack to apply to the injection site. After observing her for 30 minutes, the patient was feeling ok to leave. She was accompanied by her sister, who said she would inform us of any other adverse reactions.
Developed pain of 10/10 in arm the day after the vaccine which continues to today.  MD office visit scheduled.
Starting Thursday late afternoon I had a severe headache, temperature 100.7, chills, sweats, nausea, but then Friday early morning  my blood sugar was super high 400?s and then Saturday dropped super low 30?s, Sunday super low and Monday super low also.
Severe headache within 60 seconds of the shot. Started at the base of the neck and moved to entire head within 2 minutes. Lasted for 3 days. Still having severe headaches when I exert myself and under stress.
lit ref;p/vax pt devel rapidly progressive, symmetric, extremity weakness, facial diplegia, ophthalmoplegia, resp insufficiency & sensory ataxia; hosp;tests;dx:GBS;tx w/plasma exchange;sx worsened before stable;
pt recv vax 22OCT97 & pt stated next day large erythematous area from inj site down to elbow;presents 24OCT97 w/erythema 11x20 cm on lt deltoid & elbow region;no streaking;cool packs advised;no other special tx required;
By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed around 10 pm, I woke the following day around 4pm.  This is very unusual for me. Confined to not feel well into the next day , but by that evening I felt better.
I started to experience neuropathy, right hand, two fingers adjacent to thumb at finger tips, closest to nail bed, also in center of lower back on top of of spinal cord,  extreme pain from back and finger tips   I have recovered from illness, I have notified my employer and state Prison, the doctor at my workplace told me to file form  I am a non-smoker and I do not drink alcohol , over 15 years for both  I have also been advised from my employer (doctor) to take second dose on 17 February, 2021
Was unable to stand straight for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Was unable to stand straight for 48 hours) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 040B21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included INFLIXIMAB (REMICADE) from 24-Mar-2021 to an unknown date for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSSTASIA (Was unable to stand straight for 48 hours). At the time of the report, DYSSTASIA (Was unable to stand straight for 48 hours) outcome was unknown.            Patient was not sure of her experience was related to the vaccine.  On 14-Apr-2021 she received her second dose of the Moderna vaccine (lot no 040B21A, expiration date 01-Jan-1900) and had no problems.  She stated that she was doing fine and the side effect happened once. No treatment information was provided.
Palpitations, shortness of breath, chest tightness, presyncope, which led to New onset atrial fibrillation with rapid ventricular response and required synchronized cardioversion and hospitalization. Discharged on anticoagulation and beta-blocker.
pt recv vax & exp vaccine failure & devel chickenpox;a total of  7 patients from a daycare ctr were reported;
Muscular and joint pain; Muscular and joint pain; Lethargic; Looks like she is under anesthesia; Feeling exceedingly drained/tiredness; Her entire body is in pain; Dizziness; Jabbing pains under the arms and in her head; Jabbing pains under the arms and in her head; Weakness; Experienced swollen glands/glands got swollen; Swelling in her armpits; This is a spontaneous report from a contactable consumer. This consumer reported for 19-year-old female patient (reporter's daughter) that: A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0185 and expiry date: 31Aug2021), second dose via an unspecified route of administration on 03Jun2021 in her upper left arm, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 13May2021 (Lot Number: EW0168/EJ6795 and expiry date: 31Aug2021) in her upper left arm, single dose for COVID-19 immunisation. The patient experienced swelling in her armpits in Jun2021. On 03Jun2021 (started almost on the onset of injection), experienced weakness. In Jun2021 (started probably 2 days ago on 04Jun2021 or 05Jun2021), experienced swollen glands. On 05Jun2021, jabbing pains under the arms in her gland and inside of her head (took Tylenol and it dissipated but it was worse now than in the beginning). On 06Jun2021, feeling exceedingly drained, tiredness, dizziness and entire body was in pain. Reporter stated like this was muscular and joint pain and her daughter was very lethargic. It was informed that the last night was the hardest and her daughter describes this pain feeling like she has an elephant on top of her. On 07Jun2021 (around 3am), looks like she was under anaesthesia. The patient was experiencing pain, weakness, and tiredness which made her look like she belongs in the hospital. Reporter stated her daughter has no fever or vomiting but she has made sure her daughter has stayed on tylenol products, and fully hydrated with pedialyte. The patient taking normal medications along with Tylenol with a little bit of codeine. She had consulted briefly with her pharmacist but not taken Motrin as per pharmacist instruction. She had been drinking 3 full pedialytes per day. Now she was down for the count again and it looks like she just got the shot again and now it was the 7th day and she kind of predicted it would go on for 3 to 4 days. When patient got the vaccine she was right smack in the middle of her menstrual cycle which was rough enough on her but now her cycle was over and she was still down for the count. Reporter had concerned as her daughter takes other medications. Nothing changed her daughter and had been on the same medication for other things and it has been standard and has been on them for a year. The patient had no fever, she just took it 5 minutes ago and it was normal. The outcome of the events muscular and joint pain, lethargic were unknown rest all were not recovered.
Information has been received from medical records concerning a 22 week old female who on 17-DEC-2008 was administered the first dose of oral ROTATEQ vaccine 0.5 mL (lot #662652/1272X). Concomitant therapy included PEDIARIX 0.5 mL IM in right thigh, (lot #AC21B198BA). ACTHIB 0.5 mL in left thigh (lot #UF513AB) and PREVENAR 0.5 mL IM in left thigh (lot #C99098). On 16-Feb-2009 the patient saw the physician for a well child visit, and was vaccinated with a second dose of oral ROTATEQ. On 16-DEC-2008 she also was vaccinated with PEDIARIX 0.5 mL IM in left deltoid, (lot #AC21B1201AA), ACTHIB 0.5 mL in right deltoid (lot #UF531AA) and PREVENAR 0.5 mL IM in left deltoid. The mother was advised about growth and the baby was scheduled for another well child care visit in 2 months. On 24-MAR-2009 the baby, now 5 months old was taken to see the physician for a rash. The mother noted that the rash started about a week ago and seemed to come and go. It was mostly on her face and abdomen. Otherwise the baby was doing well with no fever, and interacting normally on physical exam the baby's skin had generalized erythematous rash, most notable on scalp. Impression by the physician was rash and other non specific skin eruption. It was prickly heat rash vs. cradle cap vs viral exanthem. The physical exam was appropriate. The mother was given instructions to keep the baby cool and exfoliate her scalp gently. She was to return to clinic if any changes. On 16-APR-2009, the baby was seen in an office visit for follow up of the rash (viral exanthem, vs prickly heat rash). The rash was now worse and was all over the body, more at skin folds such as inner elbow and thighs. It was on her face as well. Mother had been using cetaphil soap which seemed to show slight improvement, then worsened. The mother reported that the baby continuously acted normally with normal feeding, bowel movements and activity. She denied any fever. The baby however was scratching all over a lot and sometimes pulling at left ear. At the visit the baby weighed 15 lbs. Temperature was 98.6 degrees C. On examination the baby's skin had generalized eczematous rash, worse at skin folds. No vesicles were seen. She had patchy distribution of maculopapular finely scaling rash. The physician's impression was dermatitis, atopic. The rash was spreading and looked like atopic picture, despite lack of family history of the triad. The mother was encouraged to use Dove soap, cetaphil or eucerin creams. Encouraged to use vaseline on face and diaper area and for rest of body area. Over the counter cortaid creams could be used. Ear pulling was probably either random movements or baby may be teething soon. She was to return to clinic in 2-3 weeks for follow up and 6 months well child care. The mother was instructed that the baby probably had eczema and to continue with the cares as instructed. Additional information is not expected. Medical records will be provided upon request.
Shortness of breath, heart palpitations, sweating terribly .  This began on Dec 2, 2021, 10 days after the first dose. On Dec . 20, 2021, Left arm numbness with partial recovery of feeling. Left leg numbness on the way to Emergency Room. Treated for Stroke
Swollen, red, warm left thigh. Anterior bruising; size of softball. Reaction to MMR.
1/11/22 Patient presents today for video visit from home.  Patient was evaluated today using audio-visual telemedicine technology HPI     covid exposure with symptoms now Wife nurse tested + covid on  1/5 He tested neg on 1/7/22 Since 1/10 fever, ha, diarrhea + sob Dry cough at night + wheezing + lightheaded when standing up + HYPERTENSION BMI 30Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for rhinorrhea and sore throat.   Respiratory: Positive for cough, chest tightness, shortness of breath and wheezing. Negative for apnea, choking and stridor.   Cardiovascular: Negative for chest pain, palpitations and leg swelling.  Gastrointestinal: Positive for diarrhea. Negative for nausea.  Musculoskeletal: Positive for arthralgias.
(R) arm Opposite of vaccination  just above the elbow is Red and hot to the touch somewhat itchy.
This spontaneous report as received from a Doctor of pharmacy refers to a neonate patient of unknown gender who was born "sometime this week". In October 2013, the patient was vaccinated with RECOMBIVAX HB (Lot #, route and expiration date not provided) 5 mcg/0.5 ml. In October 2013, the patient inadvertently received two doses of RECOMBIVAX HB pediatric doses in 12 hours period. No adverse effects at this time. Additional information has been requested.
Severe headache starting 8/14/18 with increasing fatigue and weakness. Admitted to hospital 8/28/18 with workup revealing hemolytic anemia requiring blood transfusions, high dose steroids, and intravenous immunoglobulin.
Student present to Urgent care with a c/o pain, swelling redness to Pneumococcal site on left Deltoid along with an elevated temperature of 102.6. Student Treated by Doctor on duty, Given TYLENOL 1000mg @ 3:30 PM and Ibuprofen 200 MG at 4:PM. Student was advised to continue taking TYLENOL 325 mg  tabs  2  every 4 hours as needed and Ibuprofen 600mg every 6 hours as needed for pain Ice pack to injection site. Student instructed to return to student health service if any new or worsen symptoms in one day. Flu vaccine given Left upper deltoid Pneumococcal vaccine given Left lower deltoid.
Dystonia on right side of body effecting loss of control of movements from head to toe. Loss of coordination. Development of fibromyalgia and nerve pain. Development of a nystagmus of both eyes.
The following days I was congested, then had a sinus headache for multiple days, then was experiencing vertigo.
Swelling (6x5.5 inches), redness, warm to touch with pain.  She was given Diphenhydramine 25mg 1-2 tablets every 6 hours as needed, Tylenol for pain and told to use ice intermittently for the swelling.
A 9 year old patient came in to get a pediatric Pfizer booster. Pt was administered .3ml pediatric Pfizer that was not reconstituted with diluent first.
Patient completed second COVID vaccine and stated had a headache and some neck stiffness, but overall is doing really well.
called on 7/10 to report child screamed x 3 hrs after 3 hr nap 7/5 began vomiting with each feeding (breast) green watery diarrhea x 3 days. No fever. Alert Did not call before now as thought it needed to run its course and not life threatening.
RN spoke to grandmother, said child had multiple seizures with no temp on pm of immunizations. Had seizures again the next day, she took child to ER and was referred to pediatric neurologist. ER doctor told grandmother that seizures were probably not caused by immunizations.
Decreased or restricted appetite or diet; withdrawal of social skills; irritability; abnormal responses to voices and other environmental stimuli; decrease in eye contact or social reciprocal interactions; loss of language; bizarre play behaviors; extreme irritability. Dx'd with autism by 5/29/96. 60 day follow up states the pt has autism, heavy metal toxicity, autoimmunity, candiasis, apraxia. May never recover from these.
she received first dose of Shingrix on December 2020 and hasn't received the second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she received first dose of Shingrix on December 2020 and hasn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2023 The patient had not received the second dose of Shingrix yet. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.