chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE and FATIGUE (A little tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability NOS (Patient is disabled).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept several hours after he received the vaccine) and FATIGUE (A little tired). At the time of the report, SOMNOLENCE (Slept several hours after he received the vaccine) and FATIGUE (A little tired) outcome was unknown.            No concomitant medication and treatment information was provided.   This case was linked to MOD-2021-276487 (Patient Link).
Left arm reddened at site of injection, swollen from injection site to top of elbow, arm painful to move, "tight skin" per parent report, no fever noted.
Swelling in lower lip after first dose; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3302), via an unspecified route of administration, administered in the left arm on 18Jan2021 08:30 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergy, dust allergy, allergy to some roots, gastroesophageal reflux disease (GERD), obesity, temporomandibular joint (TMJ) syndrome, Cameron ulcers, and hiatal hernia. Prior to vaccination, the patient did not have COVID-19. Concomitant medication included omeprazole. The patient did not receive any other vaccine within 4 weeks of the COVID vaccination. On 20Jan2021, the patient experienced swelling in lower lip after first dose. The event resulted in physician office visit. The patient took Benadryl (did not help) and Prednisone (helped) for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
This case was reported in a literature article and described the occurrence of vaccination failure in a child unk subject who received Rotavirus vaccine. On an unknown date, 14 days after receiving Rotavirus vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included rotavirus gastroenteritis with serious criteria of hospitalization and GSK medically significant, diarrhea and vomiting. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included rotavirus gastroenteritis (unknown), diarrhea (unknown) and vomiting (unknown). It was unknown if the investigator considered the rotavirus gastroenteritis, diarrhea and vomiting to be related to Rotavirus vaccine. Relevant Tests: Rotavirus stool test: Positive for G1P[8] strain. Additional information received: This case was reported in a literature article and it described the occurrence of a rotavirus infection in a child of unspecified gender between 8 months and 3 years of age who had received a ROTARIX (GlaxoSmithKline). The patient had been enrolled in a study whose exclusion criteria were the following: history of immune deficiency, having been previously enrolled for the same acute gastroenteritis episode within 3 days of the current presentation or having been transferred from another hospital. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the patient received at least 1 dose of ROTARIX (oral, dosage unknown; batch number not provided). On an unspecified date either between 1 November 2009 and 30 June 2010, or between 1 November 2010 to 30 June 2011, at least 14 days after the administration of the vaccine, the patient presented to hospital with acute gastrointestinal symptoms defined by the authors as at least 3 episodes of diarrhoea and/or 1 episode of vomiting within a 24-hour-period. It was unknown if the patient was admitted or only visited the Emergency Department. G1P[8] rotavirus strain was isolated in a reverse transcription polymerase chain reaction of a faecal sample. This case was considered as a possible vaccination failure. Treatment was unknown. The outcome of the event was unspecified. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "In conclusion, this assessment of a diverse sample of children <5 years of age subject to "real-world" conditions found significant vaccine effectiveness for complete courses of both RV5 and RV1 rotavirus vaccines. No indication of waning over time was observed at the detectable limits for either vaccine, nor was there any significant difference in vaccine performance by predominant circulating strains, including the G12 genotype, which is not homotypically covered by these vaccines. Each of these rotavirus vaccines in concurrent use performed well in preventing medically attended rotavirus acute gastroenteritis episode among young children".
My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid). At the time of the report, COVID-19 (My daughter has had Moderna shot (five also) and 6 weeks ago she got Covid) outcome was unknown.            Concomitant medication was not provided. It was reported that patient had received all 5 doses of vaccine. Treatment information was not reported.   Reporter did not allow further contact
Feeling Achy; headache; nauseous to stomach; Arm hurts; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN (Feeling Achy), HEADACHE (headache), NAUSEA (nauseous to stomach) and PAIN IN EXTREMITY (Arm hurts) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 01-Apr-2021, the patient experienced PAIN (Feeling Achy), HEADACHE (headache), NAUSEA (nauseous to stomach) and PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN (Feeling Achy), HEADACHE (headache), NAUSEA (nauseous to stomach) and PAIN IN EXTREMITY (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller states next day after receiving the product,she felt crappy, achy, arm hurts, chills, nauseous to stomach and body was achy,she felt headachy and she took a couple of aspirin.
Patient had started her period prior to the vaccine on Sunday. On Monday, she described having the worst cramps and nausea she'd ever had and bled through a tampon in a short period of time. She had to go home from school and hates to miss school. This was very unusual for her.
Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM on 1/5/2021 to 0730 1/6/2021. Massive headache still lingering.
I was standing in my kitchen and felt light-headed (fell back and noticed that I was breathing fast). My heartrate was 131 and my blood pressure was 167/100. I called the hospital and they told me to come to the ER at the hospital. The ER doctors checked my blood pressure and stated that my blood pressure had increased and I was asked to sit down and my blood pressure went back down. I let him know that I did have headaches and an EKG was ordered. The doctor told me that I needed to make an appointment with a Cardiologist. My doctor decided to place a heart monitor on me as a precaution. The Cardiologist ran a CT scan to find out why my blood pressure increased after the vaccine. I did feel weak and tired for a couple of weeks after being in the hospital. I am also on Metropol as a precaution in case my blood pressure goes up to 140/90. The EKG showed that Sinus Tach Cardia. I was diagnosed with dizziness and hypertension.
14NOV96 pt rec vax & suffered a grand mal sz x 10min;fever as high as 101;EMS activated transported to hosp ER;ER MD dx grand mal sz d/t pertussis;pt d/c home from ER;t101;
37 year old female, 7 months pregnant received first dose vaccination with Pfizer-BioNTech vaccine.  Approximately 18 hours after receiving the vaccination, the individual developed dizziness, hives at site of injection, and was near to losing consciousness.  She sought medical attention in an emergency room (tests were run but no medication was given).  Discharged from emergency room but with ongoing labile blood pressure and continued vertigo.  Advised by OBGYN to not receive second dose of series.
went to MD 25NOV what pt had did not seem to be related to vax; cough, sore throat @ onset 23NOV92; cough, no fever noted; had back pain a/& was out w/that; stayed home during sickness; better now, but not over it;
Mother wrote down the date of birth on the consent form is different than what the insurance company gave when claim was rejected.
Starting within minutes of receiving the vaccine, patient starting having dizziness and nausea. The next day, starting spiking fevers to 103 degrees, which one month later, have improved (now are running around 100-101) but not yet subsided. Also has had persistent headaches, chest tightness, nausea, and body aches daily through this time as well.
day p/vax pt entire left arm swelled, unable to more, muscle spasms to left shoulder.
t came to receive her first Shingrix vaccine today along with her spouse and volunteered to receive the vaccine first.  Her husband mentioned she did not do well with vaccines as far as side effects the next day and typically had flu like symptoms.  After receiving her vaccine she stood up to stand against the wall and decided to sit down again.  I asked if she was feeling ok and she said no.  She then began having seizure-like syncope that lasted less than 20-30 seconds.  She never lost consciousness and was speaking to us as it was going on in the chair.  She mentioned how she felt like she slipped on something.  Once that stopped we carefully laid her down on the floor and raised her legs using a chair.  She mentioned she had not eaten all day and at this point it was almost noon.  After several minutes lying down we had her sit up and drink some water and have a piece of chocolate.  She then slowly got up and sat in a chair with her legs elevated for about 15 minutes or so until she felt better.  I took her blood pressure and it was 100/60.  Her husband mentioned that her blood pressure normally runs low.  He also stated that she did not like receiving vaccines and they cause her to feel nervous but had never reacted this way before.   I spoke to her doctor's nurse and explained what happened.  She stated as long as she was feeling better and had no signs of weakness it would be ok for her to go.  They scheduled an appointment for her to be seen at 4:20pm but later found out they cancelled it since she was feeling better.  I called the patient around 5:15pm and she said after going home and eating something and lying down she was feeling back to normal.  I told her to call us with any questions or concerns she may have.
Today Mom reported that her son developed hives over his body 1/2 hour after he rec'd his 1st HAV on 1-20-2012. They were at home and Mom 1st noticed them during a diaper change. No resp. trouble was noted. Mom did not treat them with any meds. and they resolved. Mom did not report this to us until today. Dr. told this RN "not" to give the HAV #2 today.
Developed hives over my entire body (legs, stomach, chest, back, butt, arms).  The hives were very itchy.  The rash lasted for one week.  I took allergy pills and used anti itch cream and calamine lotion to help with the itching.
stared with a metallic taste in mouth and fatigue. next day nausea light headed and fainted. Body aches and no appetite, joint aches.
My arm was in a lot of pain all the way to my fingertips, at first it looked like a really bad sunburn, that eventually by the end of the day was my whole arm, chest and shoulder and my side and some of my back. I couldn?t stay awake, horrible headaches, very dizzy, very swollen. I didn?t take my temperature at first, honestly I didn?t think much of it I was disoriented. As the days have passed the redness turned into a sores and the pain is still really bad and my fingers are swollen and numb but they hurt. I?ve had fevers off and on, still extremely tired. I?ve had a constant headache, I?ve been nauseous, and have vomited still dizzy, my arm feels like it?s constantly burning
28FEB94 9PM pt became lethargic, t101, foaming @ mouth, cyanotic, grunting sounds & apnea; to ER via ambulance; CXR done dx cold-congestion & was given ATB;
delirious; could not even form a thought; Dry cough; difficulty breathing; vomiting; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 79-year-old, administered in Arm Left on 23Feb2021 13:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included hypertension, glaucoma, and COVID-19. The patient had no known allergies. The patient was not pregnant. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported; latanoprost taken for an unspecified indication, start and stop date were not reported. The patient experienced delirious, could not even form a thought, dry cough, difficulty breathing, vomiting on 24Feb2021. Adverse event: February 24; All side effects listed by CDC except vomiting, also had dry cough, difficulty breathing and delirious (could not even form a thought). No treatment received for the events. The outcome of the events was recovering. The event delirious was considered as serious (medically significant).   No other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
Mother of child said "No Reaction." Already received another Booster dose.   To whom it may concern: In November 2022 our Vaccine program did our every-other-year audits in both of our offices. It was discovered at that time, that some Covid Vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received.) The Program directed us to fill out VAERS forms and send them to you. They also counselled us that it was our providers and parents joint decision as to whether to re-vaccinate pts or not.  We only use Pfizer vaccines for Covid - and the listed lot #'s given outside the expiration date are listed below.  Location #1 FM0698 (orange top) FM0698 (purple top) FL8095 (orange top) FL8094 (orange top) FM7553 (purple)  Location #2 FM0698 (purple) FP4554 (purple) FL8094 (orange) FL8095 (orange) FT1551 (orange)  Please see the attached VAERS forms, and feel free to contact the office for further questions or concerns.
rash with blisters on his shoulders and upper back; urticaria; fever; sore arm; This case was reported by a consumer via call center representative and described the occurrence of blistery rash in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, 5 days after receiving Shingrix, the patient experienced blistery rash, fever and pain in arm. On an unknown date, the outcome of the blistery rash was unknown and the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the blistery rash, fever and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The dose of Shingrix about 2.5 weeks ago.   The patient reported that he experienced sore arm and fever that resolved within about one day.  The reporter reported, that about 5 days after dose, he experienced rash with blisters on his shoulders and upper back. The reporter consented to follow up.   Follow up information received from physician on 16th April 2020: The patient's demographic details were updated. Concurrent medical conditions included seafood allergy. In March 2020, the patient experienced urticaria. The patient was treated with antihistamine and hydrocortisone. On an unknown date, the outcome of the blistery rash was recovered/resolved. The reporter considered the blistery rash and fever to be possibly related to Shingrix. The reporter considered the pain in arm to be probably related to Shingrix. The reporter considered the urticaria to be unlikely related to Shingrix.
Anaphylaxis reaction:  angioedema with generalized reddened skin, urticaria, rash, and swollen hands.
Information has been received from a certified medical assistant and a physician concerning a 15 year old female who on 26-OCT-2006 was vaccinated with the first dose of Gardasil. The patient was given the second dose on Gardasil on 13-NOV-2006. The patient experienced an allergic reaction not further specified. Additional information is not expected.
Hematoma to left arm. Metallic taste. Numbness in face and tongue.
Migraine started later that evening, on and off the next two days, nausea, chills migraine starting 72 hours later
Pt vaccinated w/DTP experienced feeling warm, hallucinations in middle of night - was hot - temp never taken, would not eat, rash all over body, lt eye swollen, temp 100; screaming & shaking & hives, listless becomes flash at times, pale.
the evening after the administration the patient developed a rash on her chest and both arms; This spontaneous report was received from a physician and refers to a 29-year-old female patient. Her concurrent conditions included allergy to sulfonamides (reported as sulfa). The patient's concomitant therapies included levothyroxine sodium (SYNTHROID). There was no information about her medical history provided.  On 03-DEC-2020, the patient was vaccinated with a first dose of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 1 injection, lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for HPV prophylaxis. On the same day, evening after the administration, the patient developed a rash on her chest and both arms. On 04-DEC-2020, she called the clinic where the vaccine was administrated for medical advice and took diphenhydramine hydrochloride (BENADRYL) for one day. There were no lab diagnostic studies performed. As for 08-DEC-2020, the patient's rash was mostly gone (reported also as recovering, but still has some rash).  Causal relationship between the event and (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Shot at 4:30. painful. Could not sleep and at 0212 episode of tachycardia/arrythmia; tremors for 6 days, headache, painful leg cramps, knees to toes; 2/19 arrhythmia/tachycardia, chest pressure. took nitro. I was in the Clinic and had a myriad of innoculations with no side effects. I get a flu shot every year with no side effects. My arm from shoulder to fingertips ached for 3-4 days. I do not want to take the second shot. Would the efficacy of the first shot be diminished by NOT getting the second one?
Pt reports initial s/s were feeling of flushing, light headed/dizziness, and "felt like my nasal cavities were swelling up, I felt like I was going to pass out."  Pt then reports that over the next 24 hours she notices facial swelling on both sides of her nose- that her nasal cavities became extremely dry- so dry it made her feel relatively short of breath---reported s/s have resolved at this time.
52 y.o. female with history as outlined below as well as pertinent history of morbid obesity and type 2 diabetes mellitus who was referred to the ER from her clinic for evaluation of new onset atrial flutter.   Acute respiratory failure with hypoxia, resolved Pneumonia due to COVID-19, improved Likely bacterial pneumonia Fever, resolved Pt with positive test for SARS-CoV-2 6 days PTA; she is vaccinated (received 2 doses of Moderna; has not received booster). Chest x-ray with findings suggestive of superimposed bacterial pneumonia (possibly improving, as patient has been on Augmentin since 12/30). Completed course while inpt w/ cefdinir, azithromycin. Placed on decadron given O2 requirements. Weaned off O2 on 1/10, stopped decadron. D-dimer was elevated 1.33 -however patient is already on Eliquis. No DVT noted on u/s. -- s/p decadron course -- s/p CAP treatment -- remains on eliquis as below     Atrial flutter with RVR, new Heart rate up to 160s on presentation, likely due to above. CHA2DS2-VASc score of 3. Over course of her admission, metoprolol added and dose increased. Diltiazem added. Continue as needed IV metoprolol. Cardiology consulted, appreciate recommendations. Started on Eliquis 5 mg twice daily. Normal TSH -- cont metoprolol, diltiazem, eliquis -- Continue telemetry monitor -- F/U up with cardiology as an outpatient   Hx of Hypertension continue lisinopril, metoprolol    Type 2 diabetes with hyperglycemia  Hx of type 2 diabetes mellitus on Metformin and glipizide PTA.  Lantus increased doses this admission and now up to 50 units twice daily while on steroids BG today a.m. was 107.  Lantus lowered from 40 BID to 40 units qhs,  She is off steroids, so requiring less insulin cont scheduled mealtime insulin as per carb count increased to 4 units per carb choice.  A1c 10.1 on January 3. Cont home oral DM regimen w/ glipizide, metformin. Cont to wean down insulin as able.    History of schizophrenia, schizoaffective disorder bipolar type, history of psychosis Resume home medications Received monthly paliperidone injection on 1/12.   Hx of OSA, obesity    VTE PPX: Eliquis Code- Full   Dispo:  No further inpatient work-up anticipated.  Awaiting group home to take the patient back